CClinicalTrials.gg
Sign In
CompletedNCT00104416Updated Jan 2, 2017Results posted

Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures

A Phase 3 interventional study of lamotrigine (LAMICTAL) extended-release and Placebo in Epilepsy, Tonic-Clonic, sponsored by GlaxoSmithKline. Completed at 146 sites in 11 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2017-01-02.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
153
Allocation
Randomized
Ages
13 Years and older
Sex
All
01

Study summary

This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

02

Conditions studied

  • Epilepsy, Tonic-Clonic

Keywords

  • antiepileptic drugs
  • seizures
  • primary generalized tonic-clonic seizures
  • Epilepsy
  • lamotrigine
  • anticonvulsants
  • LAMICTAL
03

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Is ≥13 years of age (male or female).
  • Has a confident diagnosis of epilepsy with PGTC seizures for more than 24 weeks prior to the Baseline Phase.
  • Has electroencephalogram (EEG) evidence of either spike-and-wave discharges consistent with PGTC, or at least 2 EEGs with no indication of focal abnormalities. The EEG may be historical or prospective. Investigators may use a historical EEG as long as there is appropriate documentation.
  • Has a documented history of PGTC seizures with or without other generalized seizure type(s) with no focal onset, and at least 1 PGTC seizure during the eight consecutive weeks (i.e., 56 consecutive days) prior to starting the 8-week Baseline Phase.

  • Has at least 3 PGTC seizures occurring anytime during an 8-week (i.e., 56 days) prospective Baseline Phase.

    • NOTE: When a historical baseline is used, the same time period cannot count for documentation of inclusion criteria 4 and 5. Additionally, innumerable seizure activity will not count towards the number of seizures required for randomization.

    • NOTE: With authorization from GSK, a maximum of four weeks (i.e., 28 days) of historical seizure data may replace up to four weeks (i.e., 28 days) of the prospective Baseline Phase for subjects providing reliable documentation of the following:

      1. complete daily seizure diary that includes the number of seizures experienced each day along with the exact classification of each seizure type for consecutive days prior to the prospective Baseline Phase
      2. stability of prescribed dosages of background antiepileptic drugs (AEDs)
      3. compliance with background AEDs.
    • All subjects permitted to use historical seizure data must complete a minimum of four weeks (i.e., 28 days) of the prospective Baseline Phase. The historical Baseline Phase and the prospective Baseline Phase must equal 56 consecutive days.

  • Is currently treated with a stable regimen of one or two AED(s) for at least four weeks prior to starting the Baseline Phase (historical or prospective).

    • NOTE: Benzodiazepines used chronically will be considered to be concurrent AEDs.

    • NOTE: Subjects with surgically implanted vagal nerve stimulators (VNS) will be allowed to enter the study provided that all of the following conditions are met:

      1. VNS has been in place for at least 24 weeks prior to the Baseline Phase.
      2. The settings must remain the same for at least 28 days prior to the Baseline Phase.
      3. The settings must remain the same during the Baseline, Escalation, Maintenance and Transition Phases.
      4. The battery is expected to last for the duration of the study.
      5. VNS is counted as a "concurrent AED."
  • Is able and willing to maintain an accurate and complete daily written seizure diary, or has a parent/caregiver who is able and willing to maintain an accurate and complete daily written seizure diary for the entire duration of the study.
  • Is able to comply with dosing of study drugs, background AEDs and all study procedures.
  • Has given written informed consent, or has a parent/legally authorized representative who has given written informed consent, prior to the performance of any study assessments.

  • If female, and of childbearing potential, must be using an acceptable form of birth control, to include one of the following:

    1. Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (a minimum of 3 weeks).

    2. Consistent and correct use of one of the following methods of birth control:

      • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
      • Implants of levonorgestrel
      • Injectable progestogen
      • Oral contraceptive (either combined, with at least 50mcg estrogen for women on enzyme-induced AEDs, or progestogen only)
      • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year
      • Double barrier method consisting of spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm).
      • NOTE: Women who have had a hysterectomy, tubal ligation, or are post-menopausal are considered to be of non-childbearing potential.

Exclusion criteria

Exclusion Criteria:

  • Has a history of partial seizures or interictal expression of partial seizures as evidenced by EEG NOTE: EEG may be historical or prospective.
  • Has had status epilepticus within the 24 weeks prior to, or during, the Baseline Phase.
  • Is taking three or more background AEDs chronically.
  • Has Lennox-Gastaut syndrome.
  • Is currently using or has previously used lamotrigine.
  • Is currently taking felbamate.
  • Is abusing alcohol and/or other substance(s).
  • Has taken an investigational drug within the previous 30 days or plans to take an investigational drug anytime during the study.
  • Is receiving chronic treatment with any medication that could influence seizure control. NOTE: Use of benzodiazepines is allowed.
  • Is currently following the ketogenic diet.
  • Is planning surgery to control seizures during the study.
  • Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality that are likely to interfere with the objectives of the study.
  • Has any clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs.
  • Is pregnant, breastfeeding, or planning to become pregnant during the study or within the three weeks after the last dose of study drug.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
153 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    lamotrigine (LAMICTAL) extended-relesase

    Drug: lamotrigine (LAMICTAL) extended-release

Interventions

  • Druglamotrigine (LAMICTAL) extended-release

    Primary experimental dosage form

  • DrugPlacebo

    Placebo control

05

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase

    Percent change from baseline is calculated as the number of seizures by week during the Double-Blind Treatment Phase (Treatment Week 1 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency. PGTC seizures are more commonly known as gran mal seizures.

    Time frame: Baseline through end of Double-Blind Treatment Phase (up to Week 19)

Secondary outcomes

  1. Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction in PGTC Seizure Frequency During the Entire Double-Blind (DB)Treatment Phase (TP), the Escalation Phase, the Maintenance Phase, and the Last 8 Weeks of the Maintenance Phase

    Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire DB Treatment Phase (Treatment Week 1 up to Week 19); the Escalation Phase (Treatment Week 1 up to Week 7); the Maintenance Phase (Treatment Week 8 up to Week 19); and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19), minus the seizure frequency at Baseline.

    Time frame: Entire DB Treatment Phase (Treatment Week 1 up to Week 19), Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19)

  2. Percent Change From Baseline in PGTC Seizure Frequency During the Escalation Phase, the Maintenance Phase, and During the Last 8 Weeks of the Maintenance Phase of the Double-Blind Treatment Phase

    Percent change from baseline is calculated as the number of seizures by week during the Escalation Phase (Treatment Week 1 up to Week 7), the Maintenance Phase (Treatment Week 8 up to Week 19), and during the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency.

    Time frame: Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Week 12 up to Week 19)

  3. Number of Participants With the Indicated Time to >=50% Reduction in Seizure Frequency in the Double-Blind Treatment Phase

    50% reduction in seizure frequency is defined as the time at which a participant first achieved and maintained a \>=50% reduction in seizure frequency following exposure to at least 1 week of study drug.

    Time frame: Baseline through end of Double-Blind Treatment Phase (up to Week 19)

  4. Change From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase

    Change from baseline in body weight is calculated as the Week 19 (or last on-study measurement in Double-Blind Treatment Phase) value minus the Baseline value.

    Time frame: Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)

  5. Number of Participants With Improved Clinical Status on the Investigator's Global Assessment in the Double-Blind Treatment Phase

    The investigators rated the participants' overall clinical status based on 7 clinical factors and an overall factor: seizure frequency, duration, and intensity; adverse experiences; social, intellectual, and motor functioning. Using a 7-point scale (marked deterioration \[1\], moderate deterioration \[2\], mild deterioration \[3\], no change \[4\], mild improvement \[5\], moderate improvement \[6\], or marked improvement \[7\]), the investigators assessed the participants' status compared to their condition prior to initiating study medication.

    Time frame: Week 19 (or last on-study assessment in Double-Blind Treatment Phase)

  6. Number of Participants With Improved Satisfaction With Seizure Control on the Subject Satisfaction Questionnaire in the Double-Blind Treatment Phase

    Participants were asked to rate their satisfaction with their seizure control compared to their seizure control prior to initiating study drug on a 7 point scale: marked deterioration (1), moderate deterioration (2), mild deterioration (3), no change (4), mild improvement (5), moderate improvement (6), or marked improvement (7).

    Time frame: Week 19 (or last on-study assessment in Double-Blind Treatment Phase)

  7. Percent Change From Baseline in Weekly PGTC Seizure Frequency During the Entire Continuation Phase (CP), the Transition Phase, the Open-Label Phase, and the Last 8 Weeks of the Open-Label Phase

    Percent change from baseline is calculated as the number of seizures by week during the entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52) minus the number of seizures per week during the Baseline Phase (Baseline Week 1 through Week 8). A positive number equals a reduction in seizure frequency.

    Time frame: Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)

  8. Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction or >=50% Increase From Baseline in Weekly PGTC Seizure Frequency for the Entire Continuation Phase, the Transition Phase, the Open-Label (OL) Phase, and the Last 8 Weeks of the OL Phase.

    Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire CP (CP Week 1 up to Week 52); the Transition Phase (CP Week 1 up to Week 7); the Open-Label (OL) Phase (CP Week 8 up to Week 52); and the last 8 weeks of the Open Label Phase (CP Week 45 up to Week 52) minus the seizure frequency at Baseline. W, Week.

    Time frame: Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)

  9. Mean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase

    The POMS is a self-administered 65-item questionnaire that evaluates the participants' perception of their mood state in 6 areas: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely), with higher scores indicating a more negative mood state. A total score (from 0 to 24) is obtained by summing the scores of the six domains.

    Time frame: Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)

  10. Mean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase

    The 20-item CES-D questionnaire is self-administered and asks respondents to report the frequency to which the 20 events were experienced over the past week. A 4-point Likert scale is used and ranges from rarely or none of the time (0) to most or all of the time (3). The total score, a sum across the 20 items (ranging from 0 to 60), determines the extent to which a participant may be experiencing depression. Higher scores indicate a higher severity of depression.

    Time frame: Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)

  11. Mean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase

    The NDDI-E is a self-reported questionnaire composed of 46 brief phrases/words to identify mood disorders across the spectrum of depression. It was developed to capture depressive moods that are co-morbid with the disease of epilepsy or its treatment as well as to measure the depressive state of the participant. All phrases are measured on a 4-point Likert scale of Never (1) to Always/often (4) and refer to the participants' mood over the past week. Scoring is comprised of a total mood score calculated by summing the scores of 6 specific items (from 6=never to 24=always or often).

    Time frame: Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)

  12. Mean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase

    The QOLIE-31 is a 31-item questionnaire that evaluates the participants' perception of his or her quality of life in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, and overall quality of life. Each domain (with scores ranging from 0 to 100) is summed and divided by the total number of questions that were answered. The overall score is derived by weighting and then summing up the seven domain scores.

    Time frame: Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)

  13. Mean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase

    The AEP is a list of 19 items covering many possible side effects attributable to drug treatment. The participants respond by assessing how much each event has been a problem for them over the past 4 weeks (1=Never a Problem to 4=Always a Problem). Each individual item can be examined; an overall adverse events score is calculated as the sum of the scores across the 19 items. The AEP total score ranges from 19 to 76, with a higher score indicating a higher degree of adverse event severity.

    Time frame: Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)

  14. Mean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase

    The SSQ is a self-reported instrument developed to assess the severity of seizures and seizure symptoms. The scale consists of 10 major clinical features/symptoms of seizures that the participants rate on a 7-point Likert scale (ranging from very mild/helpful/no bother at all \[1\] to very severe/no help/bothersome \[7\]). The Global Bother Domain is the primary score used for the analysis of the SSQ and has scores ranging from 1 to 7.

    Time frame: Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)

  15. Mean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase

    The ESS is an 8-item, self-administered questionnaire that measures excessive daytime sleepiness in adults. The instrument captures information on the extent to which the participant would be likely, or not, to fall asleep in certain situations. The stimulus question is: How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? Questions are answered on a 4-point scale (would never doze \[0\] to high chance of dozing \[3\]). The total score ranges from 0 to 24, where a higher score indicates a higher chance of dozing.

    Time frame: Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)

  16. Serum Concentrations and Population (POP) Pharmacokinetic Parameters for Lamotrigine

    Serum samples for participants on lamotrigine were analyzed with a validated analytical method based on solid phase extraction of serum followed by High-Performance Liquid Chromatography (HPLC) Mass Spectrometry (MS)/MS analysis. The lower limit of quantification (LLQ) for serum lamotrigine was 4 nanograms (ng)/milliliter (mL), using a 50 microliter (µL) aliquot of human serum with a higher limit of quantification (HLQ) of 4,000 ng/mL. PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.

    Time frame: Blood samples drawn at Treatment Weeks 11, 15, and 19 (or last on-study measurement in Double-Blind Treatment Phase)

06

Results

Posted May 18, 2010

Participant flow

All participants (par.) that complete the Treatment Phase (TP) and all Baseline Failures (par. who did not meet randomization seizure criteria necessary to qualify for the TP) are eligible to enter the Continuation Phase (CP). The CP is for long-term safety exposure to lamotrigine (LTG) extended release (XR); it is not a cross-over phase.

Double-Blind Phase
Participant flow — Double-Blind Phase
MilestoneDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XRContinuation Phase: Placebo/LTGContinuation Phase: LTG/LTGBaseline Failures
Started7776000
Completed6966000
Not completed810000
Withdrew: Adverse event21000
Withdrew: Lost to follow-up01000
Withdrew: Protocol violation01000
Withdrew: Withdrawal by subject23000
Withdrew: Pregnancy10000
Withdrew: Participant did not take drug34000
Continuation Phase
Participant flow — Continuation Phase
MilestoneDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XRContinuation Phase: Placebo/LTGContinuation Phase: LTG/LTGBaseline Failures
Started00696732
Completed00636527
Not completed00625
Withdrew: Adverse event00202
Withdrew: Lost to follow-up00101
Withdrew: Withdrawal by subject00211
Withdrew: Pregnancy00110
Withdrew: Non-compliance00001

Outcome measures

PrimaryPercent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase

Percent change from baseline is calculated as the number of seizures by week during the Double-Blind Treatment Phase (Treatment Week 1 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency. PGTC seizures are more commonly known as gran mal seizures.

Time frame:
Baseline through end of Double-Blind Treatment Phase (up to Week 19)
Reported as:
Median · percent change
Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase
percent changeDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase32.1 (-427 to 100)75.4 (-100 to 100)
Statistical analysis
  • Double-Blind Phase: Placebo vs Double-Blind Phase: LTG XR · Cochran-Mantel-Haenszel · p = <0.0001 · Median difference (final values): 31.6 · 95% CI 15.8 to 48.1
SecondaryNumber of Participants With >=25%, >=50%, >=75%, or 100% Reduction in PGTC Seizure Frequency During the Entire Double-Blind (DB)Treatment Phase (TP), the Escalation Phase, the Maintenance Phase, and the Last 8 Weeks of the Maintenance Phase

Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire DB Treatment Phase (Treatment Week 1 up to Week 19); the Escalation Phase (Treatment Week 1 up to Week 7); the Maintenance Phase (Treatment Week 8 up to Week 19); and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19), minus the seizure frequency at Baseline.

Time frame:
Entire DB Treatment Phase (Treatment Week 1 up to Week 19), Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19)
Reported as:
Number · participants
Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction in PGTC Seizure Frequency During the Entire Double-Blind (DB)Treatment Phase (TP), the Escalation Phase, the Maintenance Phase, and the Last 8 Weeks of the Maintenance Phase
participantsDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
>=25% reduction, Entire DB TP, n=72, 694356
>=50% reduction, Entire DB TP, n=72, 692348
>=75% reduction, Entire DB TP, n=72, 691435
100% reduction, Entire DB TP, n=72, 69714
>=25% reduction, Escalation Phase, n=72, 693951
>=50% reduction, Escalation Phase, n=72, 692338
>=75% reduction, Escalation Phase, n=72, 691424
100% reduction, Escalation Phase, n=72, 69915
>=25% reduction, Maintenance Phase, n=70, 684660
>=50% reduction, Maintenance Phase, n=70, 682951
>=75% reduction, Maintenance Phase, n=70, 681440
100% reduction, Maintenance Phase, n=70, 681031
>=25% reduction, Last 8 Weeks of MP, n=70, 684761
>=50% reduction, Last 8 Weeks of MP, n=70, 682954
>=75% reduction, Last 8 Weeks of MP, n=70, 681844
100% reduction, Last 8 Weeks of MP, n=70, 681535
SecondaryPercent Change From Baseline in PGTC Seizure Frequency During the Escalation Phase, the Maintenance Phase, and During the Last 8 Weeks of the Maintenance Phase of the Double-Blind Treatment Phase

Percent change from baseline is calculated as the number of seizures by week during the Escalation Phase (Treatment Week 1 up to Week 7), the Maintenance Phase (Treatment Week 8 up to Week 19), and during the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency.

Time frame:
Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Week 12 up to Week 19)
Reported as:
Median · percent change
Percent Change From Baseline in PGTC Seizure Frequency During the Escalation Phase, the Maintenance Phase, and During the Last 8 Weeks of the Maintenance Phase of the Double-Blind Treatment Phase
percent changeDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Escalation Phase, n=72, 6930.6 (-319 to 100)61.9 (-197 to 100)
Maintenance Phase, n=70, 6833.3 (-492 to 100)89.7 (-142 to 100)
Last 8 weeks of the Maintenance Phase, n=70, 6835.4 (-180 to 100)100.0 (-131 to 100)
SecondaryNumber of Participants With the Indicated Time to >=50% Reduction in Seizure Frequency in the Double-Blind Treatment Phase

50% reduction in seizure frequency is defined as the time at which a participant first achieved and maintained a \>=50% reduction in seizure frequency following exposure to at least 1 week of study drug.

Time frame:
Baseline through end of Double-Blind Treatment Phase (up to Week 19)
Reported as:
Number · participants
Number of Participants With the Indicated Time to >=50% Reduction in Seizure Frequency in the Double-Blind Treatment Phase
participantsDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
2 weeks1222
4 weeks1228
8 weeks1439
12 weeks2043
16 weeks2348
SecondaryChange From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase

Change from baseline in body weight is calculated as the Week 19 (or last on-study measurement in Double-Blind Treatment Phase) value minus the Baseline value.

Time frame:
Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)
Reported as:
Median · kilograms
Change From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase
kilogramsDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Change From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase1.00 (-7.7 to 10.0)0.00 (-11.4 to 8.8)
SecondaryNumber of Participants With Improved Clinical Status on the Investigator's Global Assessment in the Double-Blind Treatment Phase

The investigators rated the participants' overall clinical status based on 7 clinical factors and an overall factor: seizure frequency, duration, and intensity; adverse experiences; social, intellectual, and motor functioning. Using a 7-point scale (marked deterioration \[1\], moderate deterioration \[2\], mild deterioration \[3\], no change \[4\], mild improvement \[5\], moderate improvement \[6\], or marked improvement \[7\]), the investigators assessed the participants' status compared to their condition prior to initiating study medication.

Time frame:
Week 19 (or last on-study assessment in Double-Blind Treatment Phase)
Reported as:
Number · participants
Number of Participants With Improved Clinical Status on the Investigator's Global Assessment in the Double-Blind Treatment Phase
participantsDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Any improvement, score of 5-73657
No change, score of 43310
Any deterioration, score of 1-321
SecondaryNumber of Participants With Improved Satisfaction With Seizure Control on the Subject Satisfaction Questionnaire in the Double-Blind Treatment Phase

Participants were asked to rate their satisfaction with their seizure control compared to their seizure control prior to initiating study drug on a 7 point scale: marked deterioration (1), moderate deterioration (2), mild deterioration (3), no change (4), mild improvement (5), moderate improvement (6), or marked improvement (7).

Time frame:
Week 19 (or last on-study assessment in Double-Blind Treatment Phase)
Reported as:
Number · participants
Number of Participants With Improved Satisfaction With Seizure Control on the Subject Satisfaction Questionnaire in the Double-Blind Treatment Phase
participantsDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Any improvement, score of 5-75360
No change, score of 4136
Any deterioration, score of 1-352
SecondaryPercent Change From Baseline in Weekly PGTC Seizure Frequency During the Entire Continuation Phase (CP), the Transition Phase, the Open-Label Phase, and the Last 8 Weeks of the Open-Label Phase

Percent change from baseline is calculated as the number of seizures by week during the entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52) minus the number of seizures per week during the Baseline Phase (Baseline Week 1 through Week 8). A positive number equals a reduction in seizure frequency.

Time frame:
Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)
Reported as:
Median · percent change
Percent Change From Baseline in Weekly PGTC Seizure Frequency During the Entire Continuation Phase (CP), the Transition Phase, the Open-Label Phase, and the Last 8 Weeks of the Open-Label Phase
percent changeContinuation Phase: Placebo/LTGContinuation Phase: LTG/LTGBaseline Failures
Entire Continuation Phase, n=68, 66, 2485.2 (-113.3 to 100.0)95.1 (-100.0 to 100.0)21.7 (-115.4 to 100.0)
Transition Phase, n=68, 66, 2073.1 (-90.5 to 100.0)100.0 (-100.0 to 100.0)100.0 (-100.0 to 100.0)
Open-Label Phase, n=68, 64, 2389.2 (-116.7 to 100.0)95.0 (-100.0 to 100.0)31.7 (-194.7 to 100.0)
Last 8 weeks of Open-Label Phase, n=68, 63, 19100.0 (-184.2 to 100.0)100.0 (-53.3 to 100.0)100.0 (-500.0 to 100.0)
SecondaryNumber of Participants With >=25%, >=50%, >=75%, or 100% Reduction or >=50% Increase From Baseline in Weekly PGTC Seizure Frequency for the Entire Continuation Phase, the Transition Phase, the Open-Label (OL) Phase, and the Last 8 Weeks of the OL Phase.

Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire CP (CP Week 1 up to Week 52); the Transition Phase (CP Week 1 up to Week 7); the Open-Label (OL) Phase (CP Week 8 up to Week 52); and the last 8 weeks of the Open Label Phase (CP Week 45 up to Week 52) minus the seizure frequency at Baseline. W, Week.

Time frame:
Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)
Reported as:
Number · participants
Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction or >=50% Increase From Baseline in Weekly PGTC Seizure Frequency for the Entire Continuation Phase, the Transition Phase, the Open-Label (OL) Phase, and the Last 8 Weeks of the OL Phase.
participantsContinuation Phase: Placebo/LTGContinuation Phase: LTG/LTGBaseline Failures
>=25% reduction, Entire CP, n=68, 66, 24596311
>=50% reduction, Entire CP, n=68, 66, 24575911
>=75% reduction, Entire CP, n=68, 66, 2446498
100% reduction, Entire CP, n=68, 66, 2416286
>=50% increase, Entire CP, n=68, 66, 242110
>=25% reduction, Transition Phase, n=68, 66, 20516013
>=50% reduction, Transition Phase, n=68, 66, 20445612
>=75% reduction, Transition Phase, n=68, 66, 20334612
100% reduction, Transition Phase, n=68, 66, 20274112
>=50% increase, Transition Phase, n=68, 66, 20313
>=25% reduction, Open-Label Phase, n=68, 64, 23616112
>=50% reduction, Open-Label Phase, n=68, 64, 23565710
>=75% reduction, Open-Label Phase, n=68, 64, 2347498
100% reduction, Open-Label Phase, n=68, 64, 2321286
>=50% increase, Open-Label Phase, n=68, 64, 232110
>=25% reduction, Last 8 W of OL Phase,n=68, 63, 19606010
>=50% reduction, Last 8 W of OL Phase,n=68, 63, 19535310
>=75% reduction, Last 8 W of OL Phase,n=68, 63, 19454710
100% reduction, Last 8 W of OL Phase, n=68, 63, 19354110
>=50% increase, Last 8 W of OL Phase, n=68, 63, 19214
SecondaryMean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase

The POMS is a self-administered 65-item questionnaire that evaluates the participants' perception of their mood state in 6 areas: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely), with higher scores indicating a more negative mood state. A total score (from 0 to 24) is obtained by summing the scores of the six domains.

Time frame:
Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)
Reported as:
Least squares mean · points on a scale
Mean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase
points on a scaleDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Mean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase2.4 ± 6.979.7 ± 8.65
SecondaryMean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase

The 20-item CES-D questionnaire is self-administered and asks respondents to report the frequency to which the 20 events were experienced over the past week. A 4-point Likert scale is used and ranges from rarely or none of the time (0) to most or all of the time (3). The total score, a sum across the 20 items (ranging from 0 to 60), determines the extent to which a participant may be experiencing depression. Higher scores indicate a higher severity of depression.

Time frame:
Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)
Reported as:
Least squares mean · points on a scale
Mean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase
points on a scaleDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Mean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase2.9 ± 2.812.4 ± 2.54
SecondaryMean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase

The NDDI-E is a self-reported questionnaire composed of 46 brief phrases/words to identify mood disorders across the spectrum of depression. It was developed to capture depressive moods that are co-morbid with the disease of epilepsy or its treatment as well as to measure the depressive state of the participant. All phrases are measured on a 4-point Likert scale of Never (1) to Always/often (4) and refer to the participants' mood over the past week. Scoring is comprised of a total mood score calculated by summing the scores of 6 specific items (from 6=never to 24=always or often).

Time frame:
Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)
Reported as:
Least squares mean · points on a scale
Mean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase
points on a scaleDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Mean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase-0.1 ± 0.98-2.4 ± 1.24
SecondaryMean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase

The QOLIE-31 is a 31-item questionnaire that evaluates the participants' perception of his or her quality of life in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, and overall quality of life. Each domain (with scores ranging from 0 to 100) is summed and divided by the total number of questions that were answered. The overall score is derived by weighting and then summing up the seven domain scores.

Time frame:
Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)
Reported as:
Least squares mean · points on a scale
Mean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase
points on a scaleDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Mean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase-6.5 ± 3.97-8.5 ± 4.35
SecondaryMean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase

The AEP is a list of 19 items covering many possible side effects attributable to drug treatment. The participants respond by assessing how much each event has been a problem for them over the past 4 weeks (1=Never a Problem to 4=Always a Problem). Each individual item can be examined; an overall adverse events score is calculated as the sum of the scores across the 19 items. The AEP total score ranges from 19 to 76, with a higher score indicating a higher degree of adverse event severity.

Time frame:
Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)
Reported as:
Least squares mean · points on a scale
Mean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase
points on a scaleDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Mean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase3.0 ± 2.161.4 ± 2.77
SecondaryMean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase

The SSQ is a self-reported instrument developed to assess the severity of seizures and seizure symptoms. The scale consists of 10 major clinical features/symptoms of seizures that the participants rate on a 7-point Likert scale (ranging from very mild/helpful/no bother at all \[1\] to very severe/no help/bothersome \[7\]). The Global Bother Domain is the primary score used for the analysis of the SSQ and has scores ranging from 1 to 7.

Time frame:
Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)
Reported as:
Least squares mean · points on a scale
Mean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase
points on a scaleDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Mean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase0.86 ± 0.841.23 ± 1.08
SecondaryMean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase

The ESS is an 8-item, self-administered questionnaire that measures excessive daytime sleepiness in adults. The instrument captures information on the extent to which the participant would be likely, or not, to fall asleep in certain situations. The stimulus question is: How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? Questions are answered on a 4-point scale (would never doze \[0\] to high chance of dozing \[3\]). The total score ranges from 0 to 24, where a higher score indicates a higher chance of dozing.

Time frame:
Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)
Reported as:
Least squares mean · points on a scale
Mean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase
points on a scaleDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XR
Mean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase-0.6 ± 0.691.0 ± 0.67
SecondarySerum Concentrations and Population (POP) Pharmacokinetic Parameters for Lamotrigine

Serum samples for participants on lamotrigine were analyzed with a validated analytical method based on solid phase extraction of serum followed by High-Performance Liquid Chromatography (HPLC) Mass Spectrometry (MS)/MS analysis. The lower limit of quantification (LLQ) for serum lamotrigine was 4 nanograms (ng)/milliliter (mL), using a 50 microliter (µL) aliquot of human serum with a higher limit of quantification (HLQ) of 4,000 ng/mL. PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.

Time frame:
Blood samples drawn at Treatment Weeks 11, 15, and 19 (or last on-study measurement in Double-Blind Treatment Phase)

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Double-Blind Phase: Placebo—0/74 (0%)21/74 (28.4%)
Double-Blind Phase: LTG XR—1/72 (1.4%)27/72 (37.5%)
Continuation Phase: Placebo/LTG—3/69 (4.3%)29/69 (42%)
Continuation Phase: LTG/LTG—3/67 (4.5%)21/67 (31.3%)
Baseline Failures—1/32 (3.1%)18/32 (56.3%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XRContinuation Phase: Placebo/LTGContinuation Phase: LTG/LTGBaseline Failures
AtaxiaNervous system disorders0/740/720/690/671/32
NystagmusNervous system disorders0/740/720/690/671/32
Suicide attemptPsychiatric disorders0/740/720/690/671/32
Abdominal painGastrointestinal disorders0/740/720/690/671/32
NauseaGastrointestinal disorders0/740/720/690/671/32
VomitingGastrointestinal disorders0/740/720/690/671/32
Syncope vasovagalNervous system disorders0/740/720/691/670/32
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/740/720/691/670/32
Abortion spontaneousPregnancy, puerperium and perinatal conditions0/740/720/691/670/32
Altered state of consciousnessNervous system disorders0/740/721/690/670/32
Most frequent other events
Showing 10 of 16
Most frequent other events
EventDouble-Blind Phase: PlaceboDouble-Blind Phase: LTG XRContinuation Phase: Placebo/LTGContinuation Phase: LTG/LTGBaseline Failures
HeadacheNervous system disorders12/7410/7211/695/679/32
DizzinessNervous system disorders5/744/727/694/677/32
NauseaGastrointestinal disorders4/745/721/691/675/32
PyrexiaGeneral disorders4/745/727/695/673/32
VomitingGastrointestinal disorders3/747/725/692/672/32
TremorNervous system disorders0/744/725/693/673/32
FatigueGeneral disorders2/741/721/690/673/32
All rashSkin and subcutaneous tissue disorders4/742/722/691/672/32
DiplopiaEye disorders1/744/724/691/672/32
AtaxiaNervous system disorders0/740/722/692/672/32

Baseline characteristics

Age, Continuous
Age, Continuous(years)Double-Blind Phase: PlaceboDouble-Blind Phase: LTG XRTotal
Mean28.4 ± 11.4829.4 ± 12.7828.9 ± 12.10
Gender
Gender(Participants)Double-Blind Phase: PlaceboDouble-Blind Phase: LTG XRTotal
Female383270
Male353873
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Double-Blind Phase: PlaceboDouble-Blind Phase: LTG XRTotal
African American/African Heritage123
Asian313162
White383775
American Indian or Alaskan Native and White202
Asian and White101
07

Study locations

146 sites
  • GSK Investigational Site
    Anniston, Alabama 36207, United States
  • GSK Investigational Site
    Birmingham, Alabama 35294-0021, United States
  • GSK Investigational Site
    Northport, Alabama 35476, United States
  • GSK Investigational Site
    Tuscaloosa, Alabama 35406, United States
  • GSK Investigational Site
    Phoenix, Arizona 85006, United States
  • GSK Investigational Site
    Phoenix, Arizona 85013, United States
  • GSK Investigational Site
    Scottsdale, Arizona 85259, United States
  • GSK Investigational Site
    Tucson, Arizona 85712, United States
  • GSK Investigational Site
    Little Rock, Arkansas 72205, United States
  • GSK Investigational Site
    Los Angeles, California 90033, United States
  • GSK Investigational Site
    Los Angeles, California 90073, United States
  • GSK Investigational Site
    Newport Beach, California 92660, United States
  • GSK Investigational Site
    Santa Monica, California 90404, United States
  • GSK Investigational Site
    Sepuldeva, California 91343, United States
  • GSK Investigational Site
    Washington, District of Columbia 20037, United States
  • GSK Investigational Site
    Hollywood, Florida 33021, United States
  • GSK Investigational Site
    Maitland, Florida 32751, United States
  • GSK Investigational Site
    Ocala, Florida 34471, United States
  • GSK Investigational Site
    Atlanta, Georgia 30342, United States
  • GSK Investigational Site
    Augusta, Georgia 30912-3200, United States
  • GSK Investigational Site
    Marietta, Georgia 30060, United States
  • GSK Investigational Site
    Savannah, Georgia 31405, United States
  • GSK Investigational Site
    Suwanee, Georgia 30024, United States
  • GSK Investigational Site
    Chicago, Illinois 60612, United States
  • GSK Investigational Site
    Flossmoor, Illinois 60422, United States
  • GSK Investigational Site
    Springfield, Illinois 62702, United States
  • GSK Investigational Site
    Des Moines, Iowa 50309-1426, United States
  • GSK Investigational Site
    Wichita, Kansas 67214, United States
  • GSK Investigational Site
    Crestview Hills, Kentucky 41017, United States
  • GSK Investigational Site
    Louisville, Kentucky 40202, United States
  • GSK Investigational Site
    Lafayette, Louisiana 70503, United States
  • GSK Investigational Site
    Boston, Massachusetts 02118, United States
  • GSK Investigational Site
    Detroit, Michigan 48202, United States
  • GSK Investigational Site
    Grand Rapids, Michigan 49525, United States
  • GSK Investigational Site
    Traverse City, Michigan 49684, United States
  • GSK Investigational Site
    Minneapolis, Minnesota 55422, United States
  • GSK Investigational Site
    Minneapolis, Minnesota 55455, United States
  • GSK Investigational Site
    Chesterfield, Missouri 63017, United States
  • GSK Investigational Site
    Kansas City, Missouri 64111, United States
  • GSK Investigational Site
    Las Vegas, Nevada 89106, United States
  • GSK Investigational Site
    Edison, New Jersey 08818, United States
  • GSK Investigational Site
    West Orange, New Jersey 07052, United States
  • GSK Investigational Site
    Amherst, New York 14226, United States
  • GSK Investigational Site
    New York, New York 10016, United States
  • GSK Investigational Site
    Asheville, North Carolina 28801, United States
  • GSK Investigational Site
    Greenville, North Carolina 27834, United States
  • GSK Investigational Site
    Raleigh, North Carolina 27607, United States
  • GSK Investigational Site
    Columbus, Ohio 43210-1250, United States
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73104, United States
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73112, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19107, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19140, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15215, United States
  • GSK Investigational Site
    Germantown, Tennessee 38138, United States
  • GSK Investigational Site
    Dallas, Texas 75230, United States
  • GSK Investigational Site
    Galveston, Texas 77555, United States
  • GSK Investigational Site
    Houston, Texas 77005, United States
  • GSK Investigational Site
    San Antonio, Texas 78258, United States
  • GSK Investigational Site
    Wichita Falls, Texas 76301, United States
  • GSK Investigational Site
    Salt Lake City, Utah 84107, United States
  • GSK Investigational Site
    Burlington, Vermont 05401, United States
  • GSK Investigational Site
    Richmond, Virginia 23220, United States
  • GSK Investigational Site
    Madison, Wisconsin 53715, United States
  • GSK Investigational Site
    Milwaukee, Wisconsin 53215, United States
  • GSK Investigational Site
    Capital Federal, Buenos Aires 1181, Argentina
  • GSK Investigational Site
    Ciudad Autonoma de Buenos Aires, C1221ADC, Argentina
  • GSK Investigational Site
    Ciudad Autónoma de Buenos Aires, 1425, Argentina
  • GSK Investigational Site
    Curitiba, Paraná 80069-900, Brazil
  • GSK Investigational Site
    Campinas, São Paulo 13083-970, Brazil
  • GSK Investigational Site
    São Paulo, 05403-900, Brazil
  • GSK Investigational Site
    Santiago, Región Metro De Santiago 7571831, Chile
  • GSK Investigational Site
    Santiago, Región Metro De Santiago, Chile
  • GSK Investigational Site
    Singen, Baden-Wuerttemberg 78224, Germany
  • GSK Investigational Site
    Ulm, Baden-Wuerttemberg 89073, Germany
  • GSK Investigational Site
    Alzenau, Bayern 63755, Germany
  • GSK Investigational Site
    Bamberg, Bayern 96047, Germany
  • GSK Investigational Site
    Fuerth, Bayern 90762, Germany
  • GSK Investigational Site
    Muenchen, Bayern 80331, Germany
  • GSK Investigational Site
    Neuoetting, Bayern 84524, Germany
  • GSK Investigational Site
    Straubing, Bayern 94315, Germany
  • GSK Investigational Site
    Unterhaching, Bayern 82008, Germany
  • GSK Investigational Site
    Wuerzburg, Bayern 97070, Germany
  • GSK Investigational Site
    Bernau, Brandenburg 16321, Germany
  • GSK Investigational Site
    Ludwigsfelde, Brandenburg 14974, Germany
  • GSK Investigational Site
    Bad Homburg, Hessen 61348, Germany
  • GSK Investigational Site
    Frankfurt, Hessen 60594, Germany
  • GSK Investigational Site
    Wismar, Mecklenburg-Vorpommern 23966, Germany
  • GSK Investigational Site
    Wismar, Mecklenburg-Vorpommern 23970, Germany
  • GSK Investigational Site
    Bueckeburg, Niedersachsen 31675, Germany
  • GSK Investigational Site
    Goettingen, Niedersachsen 37075, Germany
  • GSK Investigational Site
    Osnabrueck, Niedersachsen 49074, Germany
  • GSK Investigational Site
    Baesweiler, Nordrhein-Westfalen 52499, Germany
  • GSK Investigational Site
    Bochum, Nordrhein-Westfalen 44795, Germany
  • GSK Investigational Site
    Bochum, Nordrhein-Westfalen 44892, Germany
  • GSK Investigational Site
    Essen, Nordrhein-Westfalen 45122, Germany
  • GSK Investigational Site
    Essen, Nordrhein-Westfalen 45138, Germany
  • GSK Investigational Site
    Hattingen, Nordrhein-Westfalen 45525, Germany
  • GSK Investigational Site
    Koeln, Nordrhein-Westfalen 50767, Germany
  • GSK Investigational Site
    Moenchengladbach, Nordrhein-Westfalen 41061, Germany
  • GSK Investigational Site
    Muenster, Nordrhein-Westfalen 48149, Germany

Showing the first 100 of 146 sites across 11 countries.

08

References and documents

Publications

  • Biton V, Di Memmo J, Shukla R, Lee YY, Poverennova I, Demchenko V, Saiers J, Adams B, Hammer A, Vuong A, Messenheimer J. Adjunctive lamotrigine XR for primary generalized tonic-clonic seizures in a randomized, placebo-controlled study. Epilepsy Behav. 2010 Nov;19(3):352-8. doi: 10.1016/j.yebeh.2010.07.022. Epub 2010 Oct 30. PubMed 20937567 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Registry details

Key details

Study ID
NCT00104416
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Mar 1, 2005
Start date
Dec 2004
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
May 18, 2010
Last update
Jan 2, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Epilepsy→

Other studies from this sponsor

GlaxoSmithKline

Start the discussion