CClinicalTrials.gg
Sign In
CompletedNCT00807989Updated Jul 27, 2015Results posted

The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy

A Phase 4 interventional study of Carbamazepine and Lamotrigine/Valproate in Epilepsy, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-07-27.

Sponsored by Yonsei University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
207
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce Lamotrigine metabolism.

Read the detailed description

An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies

02

Conditions studied

  • Epilepsy

Browse trials for

03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 207 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • Age ≥16yr old
  • Who are diagnosed as epilepsy definitely
  • Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months
  • Who need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2weeks)
  • Who is not pregnant
  • Who can report seizure diary by him/herself or caregiver
  • Who agree to this trial and provide informed consent.
  • Type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial motor seizures;

Exclusion criteria

Exclusion Criteria:

  • Who has progressive CNS disease.
  • Has serious systemic or psychiatric disease
  • Who is not suitable by investigator(uncooperative)
  • Who can not fill up diary check card
  • Is pregnant, breastfeeding, or planning to become pregnant
  • Exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other substance abusers, mental retardation etc.
  • Who cancels to agree to this trial and provide informed consent.
  • ALT, AST, bilirubin and BUN/Cr levels are more than twice normal range of them
  • WBC value is 2000 and less, Hb value is 9.0 and less, platelet count is 100,000 and less in CBC
  • Who took investigation products before participating this study
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
207 participants (actual)

Study arms

  • Active comparator
    Carbamazepine

    Carbamazepine

    Drug: Carbamazepine

  • Experimental
    Lamotrigine/Valproate

    Lamotrigine and Valproate combination therapy

    Drug: Lamotrigine/Valproate

Interventions

  • DrugCarbamazepine
  • DrugLamotrigine/Valproate
06

What researchers measure

Primary outcomes

  1. Retention Rate After 52 Weeks Maintenance Period

    \* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.

    Time frame: 52 weeks

Secondary outcomes

  1. Seizure Free Rate for 24 Weeks at Initial Target Dose

    Time frame: 24 weeks

  2. Seizure Free Rate for 52 Weeks at Initial Target Dose

    Time frame: 52 weeks

07

Results

Posted May 29, 2015

Participant flow

Participant flow — Overall Study
MilestoneCarbamazepineLamotrigine/Valproate
Started107100
Completed10498
Not completed32

Outcome measures

PrimaryRetention Rate After 52 Weeks Maintenance Period

\* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.

Time frame:
52 weeks
Reported as:
Number · participants
Retention Rate After 52 Weeks Maintenance Period
participantsCarbamazepineLamotrigine/Valproate
Retention Rate After 52 Weeks Maintenance Period10498
SecondarySeizure Free Rate for 24 Weeks at Initial Target Dose
Time frame:
24 weeks
Reported as:
Number · participants
Seizure Free Rate for 24 Weeks at Initial Target Dose
participantsCarbamazepineLamotrigine/Valproate
Seizure Free Rate for 24 Weeks at Initial Target Dose5159
SecondarySeizure Free Rate for 52 Weeks at Initial Target Dose
Time frame:
52 weeks
Reported as:
Number · participants
Seizure Free Rate for 52 Weeks at Initial Target Dose
participantsCarbamazepineLamotrigine/Valproate
Seizure Free Rate for 52 Weeks at Initial Target Dose4350

Adverse events

Collected over 52 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Carbamazepine—9/104 (8.7%)60/104 (57.7%)
Lamotrigine/Valproate—0/98 (0%)59/98 (60.2%)
Most frequent serious events
Most frequent serious events
EventCarbamazepineLamotrigine/Valproate
Meningoencephalitis herpeticInfections and infestations1/1040/98
PneumoniaInfections and infestations1/1040/98
Alcoholic seizureNervous system disorders1/1040/98
Atonic seizuresNervous system disorders1/1040/98
Ventricular tachycardiaCardiac disorders1/1040/98
Joint dislocationInjury, poisoning and procedural complications1/1040/98
Facet joint syndromeMusculoskeletal and connective tissue disorders1/1040/98
Abnormal behaviourPsychiatric disorders1/1040/98
Skin rashSkin and subcutaneous tissue disorders1/1040/98
HospitalisationSurgical and medical procedures1/1040/98
Most frequent other events
Most frequent other events
EventCarbamazepineLamotrigine/Valproate
HeadacheNervous system disorders26/10426/98
DizzinessNervous system disorders18/10417/98
SomnolenceNervous system disorders14/10412/98
TremorNervous system disorders2/10411/98
NasopharyngitisInfections and infestations7/10410/98
Memory impairmentNervous system disorders10/1045/98
FatigueGeneral disorders10/1044/98
Weight gainMetabolism and nutrition disorders9/1046/98
Skin rashSkin and subcutaneous tissue disorders7/1046/98
DyspepsiaGastrointestinal disorders7/1045/98

Baseline characteristics

Age, Continuous
Age, Continuous(Year)CarbamazepineLamotrigine/ValproateTotal
Mean33.2 ± 14.636.5 ± 13.734.8 ± 14.2
Sex: Female, Male
Sex: Female, Male(Participants)CarbamazepineLamotrigine/ValproateTotal
Female514899
Male5350103
Region of Enrollment
Region of Enrollment(participants)CarbamazepineLamotrigine/ValproateTotal
Korea, Republic of10498202
08

Study locations

1 site
  • Yonsei Medical Center
    Seoul, 120-752, Korea, Republic of
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00807989
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Dec 15, 2008
Start date
Mar 2008
Primary completion
May 2012
Completion
May 2012
Results posted
May 29, 2015
Last update
Jul 27, 2015

Study contacts

Byung-In Lee
principal investigator · Yonsei Univ.
Kyoung Heo
principal investigator · Yonsei Univ.
Sang-Kun Lee
principal investigator · Seoul National Univ.
Sang-Ahm Lee
principal investigator · Ulsan Univ.
Dong-Jin Shin
principal investigator · Gacheon Univ.
Hong-Ki Song
principal investigator · Hallym Univ.
Young-In Kim
principal investigator · Catholic Univ.
Se-Jin Lee
principal investigator · Youngnam Univ.
Sang-Ho Kim
principal investigator · Donga Univ.
Myung-Gyu Kim
principal investigator · Cheonnam Univ.
Yo-Sik Kim
principal investigator · Wonkwang Univ.
Sang-Do Lee
principal investigator · Dongsan Hosp.
Sung-Eun Kim
principal investigator · Pusan-Bak Hosp.
Sung-Pa Park
principal investigator · Kyungbuk Univ.
Joo-Yong Kim
principal investigator · Hanrim Univ.
Ok-Jun Kim
principal investigator · Bundang Cha
Soon-Ki Noh
principal investigator · Bong-Sang Hosp.
Hyang-Woon Lee
principal investigator · I-wha Univ.
Jae-Moon Kim
principal investigator · Chungnam Univ.

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2015. 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

Yonsei University

Start the discussion