CompletedNCT00742209Updated Jul 22, 2013Results posted

Prevention Study in Adult Patients Suffering From Migraine Headaches

A Phase 2 interventional study of GSK1838262 and Placebo in Migraine Disorders and Migraine, sponsored by XenoPort, Inc.. Completed at 59 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-22.

Sponsored by XenoPort, Inc. · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 526
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Purpose of the study is to evaluate dose response relationship, efficacy, safety and tolerability of target doses of GSK1838262 compared to placebo in the prophylactic treatment of migraine headache. Once subjects complete the baseline and meet the randomization criteria, they will complete a 5-wk flexible titration period and then enter the 12 week maintenance period.

Read the detailed description

MPX111381 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, flexible-dose evaluation of GSK1838262 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day compared with placebo in the prophylactic treatment of migraine headache.

Subjects 18 years of age must have experienced at least three migraine headache attacks (with or without aura according to 2004 International Headache Society [IHS] criteria 1.1 and 1.2.1) per month during the 3 months prior to screening and at least four migraine headache days but less than 15 total headache days (migraine or non-migraine) per month during the 3 months prior to screening and must maintain this requirement throughout the last 4 weeks of the baseline period. Approximately 528 subjects from approximately 53 centers in North America will be randomized in a 2:1:2:2:1 ratio to the following treatment groups: placebo, GSK1838262 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day. Investigational product will be administered twice daily (morning and evening) with food (e.g., meal or snack).

The study will consist of six study periods for a total study duration of up to 30 weeks: Screening (2 weeks), baseline (including randomization, 6 weeks), flexible titration (5 weeks), maintenance (12 weeks), taper (3 weeks) and post-treatment (2 weeks). The flexible titration administration of investigational product is designed to allow subjects to reach the target dose for maintenance treatment or, if unable to reach this target dose, to achieve a maximum tolerated dose for maintenance treatment. Subjects will have the opportunity to undergo a single dose (600 mg/day) downward adjustment during the flexible titration period if intolerability at the current dose occurs. Subsequently, if a single dose downward adjustment has occurred, no further dose adjustments in the study (upward or downward) will be permitted.

Conditions studied

Migraine Disorders
Migraine

Browse trials for

Keywords

migraine
prophylaxis
prevention

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 526 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

XenoPort, Inc. is the lead sponsor of 26 studies on the registry; none are open to participants now.

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

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Outpatient subjects aged 18 years or older.
Females of non-childbearing potential. If of child-bearing potential, is not lactating and has a negative pregnancy test 7 days prior to study treatment initiation and agrees to use one of the GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy.
Subjects suffering from migraine headache with or without aura, according to 2004 IHS criteria 1.1 and 1.2.1.
Subject has had a history of migraine headache for at least one year, and the age of onset was prior to 50 years.
Subject has consistent migraine headache over time (i.e., incidence and severity).
Subject has had at least three migraine headache attacks per month during the 3 months prior to screening and maintains this requirement during the last 4 weeks of the baseline period
Subject has had at least four migraine headache days but less than 15 total headache days (migraine or non-migraine) per month during the 3 months prior to screening and maintains this requirement during the last 4 weeks of the baseline period.
Subject is able to distinguish migraine headache attacks as discrete from other headaches (i.e., tension-type headaches).
Subject has the ability to read, comprehend and legibly and reliably record information in paper and electronic format as required by the protocol.
Subject must be able to provide written informed consent prior to participation in the study. The contents and process of obtaining informed consent will be in accordance with all applicable regulatory requirements.

Exclusion criteria

Exclusion Criteria:

Subject has a history of ergotamine, triptan, opioid, and/or combination pain medication use on >/=10 days per month on a regular basis for >/= 3 months.
Subject has failed more than 2 adequate treatments of migraine prophylaxis -where failure is defined as a lack of efficacy with treatment duration of at least 8 weeks.
Subject has history of simple analgesic use on >/=15 days per month for >/=3months.
Subject is unable to discontinue prohibited medications during the 2-week screening period and throughout the duration of the study including beta-blockers, benzodiazepines, tricyclic antidepressants, calcium channel blockers, antiepileptic drugs, bupropion or serotonergic noradrenergic reuptake inhibitors (SNRIs).
Subjects who have taken gabapentin or pregabalin previously for the prophylactic treatment of migraine headache. Subjects who have taken gabapentin or pregabalin for treatment of conditions other than migraine are eligible provided, (1) their total exposure to gabapentin and pregabalin is less than 3 months during the preceding 12 months, and (2) the subject stopped taking gabapentin or pregabalin for at least 3 months prior to baseline.
Subject has a history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches.
Subject has a current or past history of seizure disorder.
Subject has any of the following medical conditions, laboratory abnormalities or disorders:
Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) or alkaline phosphatase or bilirubin >1.5x ULN
Chronic hepatitis B or C with a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C Core Antigen Antibody (Hep C antibody)
Impaired renal function defined as either creatinine clearance \<60 mL/min (estimation of creatinine clearance by Cockroft and Gault Method) or renal dysfunction requiring hemodialysis
Corrected QT (QTc) interval >/= 450 msec based on the average QTc value of triplicate electrocardiograms (ECGs) obtained by the central ECG reader over a brief recording period
QTc interval >/= 480 msec for subjects with Bundle Branch Block based on the average QTc value of triplicate ECGs obtained by the central ECG reader over a brief recording period
Uncontrolled hypertension at screen or at time of randomization (sitting systolic blood pressure [SBP] >160 mmHg and/or sitting diastolic blood pressure [DBP] >90 mmHg)
Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GSK1838262, or, in the investigator's judgement:
Is considered to be clinically significant and may pose a safety concern, or,
Could interfere with the accurate assessment of safety or efficacy, or,
Could potentially affect a subject's safety or study outcome.
Subject meets criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for a major depressive episode or for active significant psychiatric disorders within the past year, including dementia, general anxiety disorder, psychotic disorders or bipolar disorder.
Subjects with a history of depression that is in remission, with or without antidepressant treatment, may participate, unless a stable antidepressant regimen includes a prohibited medication.
Antidepressant medication may not be changed or discontinued to meet entry criteria and must be stable for at least 3 months prior to screening.
Subject has a history of clinically significant drug or alcohol abuse as defined by DSM IV TR or is unable to refrain from substance abuse throughout the study.
Subject is currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device.
Subject has participated in a clinical study in which the subject was exposed to an investigational or non investigational drug or device:
Within the preceding month for studies unrelated to the current illness (migraine headaches), or
Within the preceding 3 months for studies related to the current illness (migraine headaches).
Subjects who have taken botulinum toxin type A (Botox) within the past 6 months.
Subject has a history of an allergic reaction, or a medically significant adverse reaction to the investigational product or excipients, which, in the opinion of the investigator, makes a subject unsuitable for participation in the study.
Subject is felt to be at risk of non-compliance (e.g., for taking investigational product or for completing the electronic diary [e-diary]), in the investigator's opinion.
Subject is a pregnant or nursing woman.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 526 participants (actual)

Study arms

Placebo comparator
Placebo
PBO
Drug: Placebo
Active comparator
GSK 1838262 1200 mg/day
600 or 1200 mg/day
Drug: GSK1838262
Active comparator
GSK 1838262 1800 mg/day
600 or 1200 or 1800 mg/day
Drug: GSK1838262
Active comparator
GSK 1838262 2400 mg/day
600 or 1200 or 1800 or 2400 mg/day
Drug: GSK1838262
Active comparator
GSK 1838262 3000 mg/day
600 or 1200 or 1800 or 2400 or 3000 mg/day
Drug: GSK1838262

Interventions

DrugGSK1838262
Flexible dosing: 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day
Also known as: XP13512
DrugPlacebo
Placebo-control

What researchers measure

Primary outcomes

Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper
A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Secondary outcomes

Mean Change From Baseline in the Number of MHD in All Study Phases
A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Adjusted Mean Change From Baseline in the Number of Migraine Attacks
A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)
A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Change From Baseline in the Mean Migraine Attack Duration
The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Change From Baseline in the Mean Peak Migraine Pain Severity
Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use
The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered
The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use
The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use
The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use
The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia
The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack.
Time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods
A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures.
Time frame: Baseline to the Last 4 weeks of treatment
Number of Participants Who Were "Much Improved" or "Very Much Improved" on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17
The PGIC is a single question measured on the 7-point Likert Scale (1 = "very much improved"; 2 = "much improved"; 7 = "very much worse"). A responder is defined as being "very much improved" or "much improved."
Time frame: Week 17
Number of Participants Who Were "Much Improved" or "Very Much Improved" (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17
The CGIC is a single question measured on a 7-point Likert Scale. (1 = "very much improved"; 2= "much improved, and 7 = "very much worse") designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'.
Time frame: Week 17

Other outcomes

Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17
The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status.
Time frame: Baseline and Week 17
Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17
The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life.
Time frame: Week 17
Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)
Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant.
Time frame: Week 17
Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17
Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting "Very Satisfied" (scale value = 1) or "Satisfied" (scale value = 2) on the scale.
Time frame: Week 17

Results

Posted Dec 5, 2011

Participant flow

Participant flow — Overall Study
Milestone	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Started	129	67	134	134	62
Completed	95	49	88	97	37
Not completed	34	18	46	37	25
Withdrew: Adverse event	11	4	17	16	13
Withdrew: Participant withdrew consent	8	4	14	7	4
Withdrew: Protocol violation	6	5	4	5	3
Withdrew: Lost to follow-up	3	4	5	5	3
Withdrew: Lack of efficacy	6	1	1	3	1
Withdrew: Investigator discretion	0	0	5	1	1

Outcome measures

PrimaryAdjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper

A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Least squares mean · Migraine Headache Days (MHD)

Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper
Migraine Headache Days (MHD)	Placebo	Average of GEn 1800/2400 mg	GEn 1800 mg	GEn 2400 mg
Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper	-3.8 ± 0.38	-3.6 ± 0.26	-3.8 ± 0.37	-3.3 ± 0.37

Statistical analysis

Placebo vs Average of GEn 1800/2400 mg · ANCOVA · p = 0.579 (A combination of a sequential method and the Hochberg procedure has been used to maintain the overall experiment-size alphas level of 0.05 for the comparison of GEn vs. placebo.) · Adjusted mean difference versus placebo: 0.3 · 95% CI -0.6 to 1.1Adjusted mean difference versus placebo

SecondaryMean Change From Baseline in the Number of MHD in All Study Phases

A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Migraine Headache Days (MHD)

Mean Change From Baseline in the Number of MHD in All Study Phases
Migraine Headache Days (MHD)	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Baseline to Titration(n=124, 59, 119, 124, 59)	-2.434 ± 0.3621	-1.920 ± 0.5224	-2.431 ± 0.3375	-2.573 ± 0.3352	-2.325 ± 0.5055
Baseline to 2nd 4-Week (n=124, 59, 119, 124, 59)	-3.595 ± 0.3784	-2.739 ± 0.6897	-3.953 ± 0.3794	-3.360 ± 0.4201	-3.520 ± 0.5669
Baseline to 3rd 4-Week (n=124, 59, 119, 124, 59)	-3.865 ± 0.3992	-3.171 ± 0.6660	-3.9888 ± 0.3810	-3.439 ± 0.4483	-3.220 ± 0.6594
Baseline to Maint Phase (n=112, 54, 101, 107)	-3.846 ± 0.3589	-2.854 ± 0.6565	-4.047 ± 0.3368	-3.794 ± 0.3761	-3.723 ± 0.6492
Baseline to Treat Phase (n=118, 56, 113, 118, 56)	-3.396 ± 0.3422	-2.834 ± 0.5640	-3.579 ± 0.3140	-3.393 ± 0.3388	-3.193 ± 0.5165
Baseline to 1st 4-Week (n=124, 59, 119,124, 59)	-3.147 ± 0.4043	-2.191 ± 0.6758	-3.424 ± 0.3204	-3.419 ± 0.3941	-2.974 ± 0.5522

SecondaryAdjusted Mean Change From Baseline in the Number of Migraine Attacks

A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Migraine Attacks

Adjusted Mean Change From Baseline in the Number of Migraine Attacks
Migraine Attacks	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Adjusted Mean Change From Baseline in the Number of Migraine Attacks	-2.2 ± 0.15	-2.2 ± 0.22	-2.3 ± 0.16	-2.1 ± 0.15	-2.6 ± 0.22

SecondaryMean Change From Baseline in the Number of Migraine Headache Periods (MHP)

A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Migraine Headache Periods (MHP)

Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)
Migraine Headache Periods (MHP)	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)	-3.3 ± 0.35	-3.0 ± 0.50	-3.6 ± 0.36	-3.0 ± 0.34	-3.2 ± 0.50

SecondaryChange From Baseline in the Mean Migraine Attack Duration

The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Hours

Change From Baseline in the Mean Migraine Attack Duration
Hours	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Change From Baseline in the Mean Migraine Attack Duration	-0.97 ± 3.355	3.01 ± 5.720	-2.93 ± 3.658	2.59 ± 5.000	9.82 ± 9.975

SecondaryChange From Baseline in the Mean Peak Migraine Pain Severity

Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Scores on a Scale

Change From Baseline in the Mean Peak Migraine Pain Severity
Scores on a Scale	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Change From Baseline in the Mean Peak Migraine Pain Severity	-0.12 ± 0.058	-0.13 ± 0.086	-0.12 ± 0.055	-0.04 ± 0.050	-0.09 ± 0.080

SecondaryMean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use

The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Days

Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use
Days	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use	-2.0 ± 0.28	-2.3 ± 0.39	-2.7 ± 0.28	-2.2 ± 0.27	-2.1 ± 0.40

SecondaryMean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered

The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Acute Medication Doses Admin.

Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered
Acute Medication Doses Admin.	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered	-4.5 ± 0.69	-4.8 ± 0.97	-5.8 ± 0.70	-5.1 ± 0.67	-4.5 ± 0.69

SecondaryMean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use

The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Acute Migraine Medication Dose

Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use
Acute Migraine Medication Dose	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Triptan Use (n= 72, 30, 65, 63, 32)	-3.3 ± 0.88	-2.9 ± 1.35	-4.9 ± 0.91	-4.3 ± 0.93	-2.6 ± 1.31
Not a Triptan User (n = 48, 29, 49, 60, 26)	-6.3 ± 1.06	-6.7 ± 1.36	-6.9 ± 1.05	-6.0 ± 0.95	-6.8 ± 1.44

SecondaryMean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use

The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Days

Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use
Days	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Opioid Use (n=20, 7, 14, 26, 10)	-1.7 ± 1.66	1.4 ± 2.81	-3.2 ± 1.97	-6.0 ± 1.45	-5.1 ± 2.34
Non-Opioid Use (n=100, 52, 100, 97, 48)	-5.1 ± 0.75	-5.7 ± 0.75	-6.2 ± 0.74	-4.9 ± 0.75	-4.4 ± 1.08

SecondaryMean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use

The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Acute Migraine Medication Doses

Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use
Acute Migraine Medication Doses	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Uses Prescription HA meds (n=89, 38, 80, 88, 39)	-3.6 ± 0.78	-3.5 ± 1.19	-4.9 ± 0.82	-4.0 ± 0.78	-3.3 ± 1.18
Uses OTC HA meds only (n=31, 21, 34, 35, 19)	-6.9 ± 1.31	-7.2 ± 1.59	-7.8 ± 1.25	-7.9 ± 1.23	-6.9 ± 1.68

SecondaryMean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia

The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack.

Time frame:: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)
Reported as:: Mean · Percentage of MA with migraine symptoms

Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia
Percentage of MA with migraine symptoms	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Aura (n=99, 52, 89, 102, 44)	-7.4 ± 3.640	-3.37 ± 4.834	-7.43 ± 3.230	-0.72 ± 3.044	1.21 ± 4.372
Nausea (n=125, 62, 123, 121, 59)	-7.8 ± 2.73	-3.6 ± 3.92	-8.4 ± 3.01	-5.4 ± 2.50	1.4 ± 3.31
Vomiting (n=99, 52, 89, 102, 44)	0 ± 2.60	-0.9 ± 2.98	-0.4 ± 3.01	3.7 ± 0.4	0.4 ± 4.83
Photophobia (n=99, 52, 89, 102, 44)	-1.9 ± 2.82	-3.5 ± 4.09	-2.1 ± 2.86	-5.5 ± 2.64	0.1 ± 2.49
Phonophobia (n=99, 52, 89, 102, 44)	-5.4 ± 3.14	1.2 ± 3.05	-0.7 ± 3.42	-7.4 ± 2.88	3.6 ± 1.93

SecondaryPercentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods

A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures.

Time frame:: Baseline to the Last 4 weeks of treatment
Reported as:: Number · percentage of participants

Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods
percentage of participants	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Migraine headache days (n=65, 26, 68, 67, 38)	54	44	60	54	66
Migraine attacks (n=64, 31, 67, 67, 39)	53	53	59	54	67
Migraine headache periods (n=65, 27, 70, 69, 40)	54	46	61	56	69

SecondaryNumber of Participants Who Were "Much Improved" or "Very Much Improved" on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17

The PGIC is a single question measured on the 7-point Likert Scale (1 = "very much improved"; 2 = "much improved"; 7 = "very much worse"). A responder is defined as being "very much improved" or "much improved."

Time frame:: Week 17
Reported as:: Number · participants

Number of Participants Who Were "Much Improved" or "Very Much Improved" on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17
participants	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Number of Participants Who Were "Much Improved" or "Very Much Improved" on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17	71	40	84	81	36

SecondaryNumber of Participants Who Were "Much Improved" or "Very Much Improved" (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17

The CGIC is a single question measured on a 7-point Likert Scale. (1 = "very much improved"; 2= "much improved, and 7 = "very much worse") designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'.

Time frame:: Week 17
Reported as:: Number · Participants

Number of Participants Who Were "Much Improved" or "Very Much Improved" (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17
Participants	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Number of Participants Who Were "Much Improved" or "Very Much Improved" (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17	75	40	84	85	32

Other pre-specifiedMean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17

The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status.

Time frame:: Baseline and Week 17
Reported as:: Mean · units on a scale

Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17
units on a scale	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Role Function Restrictive	30.7 ± 2.31	38.7 ± 3.12	37.1 ± 2.38	32.8 ± 2.28	30.9 ± 3.73
Role Function Preventive	22.7 ± 1.98	28.6 ± 2.67	28.0 ± 2.04	23.9 ± 1.96	22.4 ± 3.20
Emotional Function	29.7 ± 2.56	37.0 ± 3.46	34.8 ± 2.64	30.4 ± 2.54	25.7 ± 4.14

Other pre-specifiedMean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17

The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life.

Time frame:: Week 17
Reported as:: Mean · Points on a scale

Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17
Points on a scale	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17	-10.0 ± 0.95	-12.2 ± 1.28	-11.8 ± 0.98	-9.8 ± 0.94	-10.3 ± 1.53

Other pre-specifiedMean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)

Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant.

Time frame:: Week 17
Reported as:: Mean · Hours

Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)
Hours	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
Lost Work Time (n=52, 23, 41, 35, 17)	-0.8 ± 0.49	-0.3 ± 0.73	-0.9 ± 0.55	-0.1 ± 0.59	0.8 ± 0.85
Lost Activity Time (n=99,52, 89, 102, 44)	0.1 ± 0.74	-0.1 ± 1.02	-1.2 ± 0.78	-1.0 ± 0.73	1.7 ± 1.11
Lost Time Equivalents (n=99, 52, 89, 102, 44)	-0.2 ± 0.83	-0.5 ± 1.14	-1.7 ± 0.87	-1.1 ± 0.082	2.1 ± 1.24

Other pre-specifiedAssessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17

Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting "Very Satisfied" (scale value = 1) or "Satisfied" (scale value = 2) on the scale.

Time frame:: Week 17
Reported as:: Number · Percentage of Patients

Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17
Percentage of Patients	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
How Effective Overall	74	39	84	81	36
Side Effects of the Medication	79	32	72	75	28
Overall Satisfaction with Medication	76	39	84	84	34

Adverse events

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

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	2/128 (1.6%)	86/128 (67.2%)
GEn 1200 mg	—	0/66 (0%)	44/66 (66.7%)
GEn 1800 mg	—	2/134 (1.5%)	99/134 (73.9%)
GEn 2400 mg	—	1/133 (0.8%)	101/133 (75.9%)
GEn 3000 mg	—	4/62 (6.5%)	47/62 (75.8%)

Most frequent serious events

Showing 10 of 11

Most frequent serious events
Event	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
PneumoniaInfections and infestations	0/128	0/66	0/134	0/133	1/62
Metastatic malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/128	0/66	0/134	0/133	1/62
ConvulsionNervous system disorders	0/128	0/66	0/134	0/133	1/62
Conversion disorderPsychiatric disorders	0/128	0/66	0/134	0/133	1/62
PharyngitisInfections and infestations	1/128	0/66	0/134	0/133	0/62
Muscle SpasmsMusculoskeletal and connective tissue disorders	1/128	0/66	0/134	0/133	0/62
Accidental OverdoseInjury, poisoning and procedural complications	0/128	0/66	0/134	1/133	0/62
AppendicitisInfections and infestations	0/128	0/66	1/134	0/133	0/62
CholecystitisHepatobiliary disorders	0/128	0/66	1/134	0/133	0/62
CholeslithiasisHepatobiliary disorders	0/128	0/66	1/134	0/133	0/62

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg
DizzinessNervous system disorders	8/128	16/66	43/134	35/133	11/62
FatigueGeneral disorders	9/128	10/66	12/134	14/133	3/62
SomnolenceNervous system disorders	6/128	6/66	7/134	14/133	9/62
NauseaGastrointestinal disorders	12/128	3/66	15/134	12/133	6/62
Upper respiratory track infectionRespiratory, thoracic and mediastinal disorders	9/128	4/66	4/134	9/133	5/62
ConstipationGastrointestinal disorders	3/128	4/66	7/134	8/133	5/62
Weight increasedInvestigations	7/128	4/66	8/134	9/133	4/62
NasopharyngitisInfections and infestations	8/128	3/66	4/134	4/133	2/62
DiarrhoeaGastrointestinal disorders	8/128	1/66	1/134	7/133	1/62
Dry mouthSkin and subcutaneous tissue disorders	3/128	4/66	6/134	5/133	3/62

Baseline characteristics

Intent to Treat population

Age Continuous
Age Continuous(years)	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg	Total
Mean	41.1 ± 11.72	39.4 ± 9.74	37.7 ± 11.75	39.0 ± 12.04	39.1 ± 11.78	39.2 ± 11.61

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg	Total
Female	111	52	115	105	46	429
Male	17	14	19	28	16	94

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Placebo	GEn 1200 mg	GEn 1800 mg	GEn 2400 mg	GEn 3000 mg	Total
White	108	54	107	112	53	434
African American/African Heritage (AA)	11	8	15	11	6	51
American Indian (AI) or Alaska Native (AN)	2	1	3	1	0	7
Asian	4	3	6	6	3	22
Native Hawaiian or other Pacific Islander	1	0	0	0	0	1
AA/African Heritage and AI or AN and White	0	0	0	1	0	1
AA/African Heritage and White	0	0	2	1	0	3
AI or AN and White	1	0	1	0	0	2
Asian and White	1	0	0	1	0	2

Study locations

59 sites

GSK Investigational Site
Birmingham, Alabama 35233, United States
GSK Investigational Site
Phoenix, Arizona 85016, United States
GSK Investigational Site
Phoenix, Arizona 85023, United States
GSK Investigational Site
Anaheim, California 92801, United States
GSK Investigational Site
Newport Beach, California 92660, United States
GSK Investigational Site
Redlands, California 92374, United States
GSK Investigational Site
San Francisco, California 94109, United States
GSK Investigational Site
Santa Monica, California 90404, United States
GSK Investigational Site
Westlake Village, California 91361, United States
GSK Investigational Site
Colorado Springs, Colorado 80904, United States
GSK Investigational Site
Colorado Springs, Colorado 80909, United States
GSK Investigational Site
Denver, Colorado 80239, United States
GSK Investigational Site
Deland, Florida 32720, United States
GSK Investigational Site
Sunrise, Florida 33351, United States
GSK Investigational Site
West Palm Beach, Florida 33407, United States
GSK Investigational Site
Atlanta, Georgia 30308, United States
GSK Investigational Site
Stockbridge, Georgia 30281, United States
GSK Investigational Site
Chicago, Illinois 60642, United States
GSK Investigational Site
Wichita, Kansas 67207, United States
GSK Investigational Site
Kalamazoo, Michigan 49009, United States
GSK Investigational Site
Golden Valley, Minnesota 55422, United States
GSK Investigational Site
Kansas City, Missouri 64111, United States
GSK Investigational Site
Springfield, Missouri 65807, United States
GSK Investigational Site
St. Louis, Missouri 63141, United States
GSK Investigational Site
Las Vegas, Nevada 89119, United States
GSK Investigational Site
Albany, New York 12206, United States
GSK Investigational Site
Greensboro, North Carolina 27405, United States
GSK Investigational Site
Raleigh, North Carolina 27607, United States
GSK Investigational Site
Raleigh, North Carolina 27609, United States
GSK Investigational Site
Cleveland, Ohio 44195, United States
GSK Investigational Site
West Chester, Ohio 45069, United States
GSK Investigational Site
Westerville, Ohio 43081, United States
GSK Investigational Site
Philadelphia, Pennsylvania 19107, United States
GSK Investigational Site
Philadelphia, Pennsylvania 19139, United States
GSK Investigational Site
Pittsburgh, Pennsylvania 15236, United States
GSK Investigational Site
Charleston, South Carolina 29412, United States
GSK Investigational Site
Memphis, Tennessee 38018, United States
GSK Investigational Site
Nashville, Tennessee 37203, United States
GSK Investigational Site
Houston, Texas 77004, United States
GSK Investigational Site
San Antonio, Texas 78205, United States
GSK Investigational Site
Salt Lake City, Utah 84109, United States
GSK Investigational Site
Salt Lake City, Utah 84121, United States
GSK Investigational Site
Alexandria, Virginia 22311, United States
GSK Investigational Site
Seattle, Washington 98195, United States
GSK Investigational Site
Wenatchee, Washington 98801, United States
GSK Investigational Site
Penticton, British Columbia V2A 5C8, Canada
GSK Investigational Site
Surrey, British Columbia V4H 2H9, Canada
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador A0A 1G0, Canada
GSK Investigational Site
Brampton, Ontario L6T 3T1, Canada
GSK Investigational Site
Ottawa, Ontario K1H 1A2, Canada
GSK Investigational Site
Ottawa, Ontario K2G 6E2, Canada
GSK Investigational Site
Sudbury, Ontario P3E 1H5, Canada
GSK Investigational Site
Toronto, Ontario M3H 5S4, Canada
GSK Investigational Site
Toronto, Ontario M4S 1Y2, Canada
GSK Investigational Site
Toronto, Ontario M9W 4L6, Canada
GSK Investigational Site
Montreal, Quebec H2W 1V1, Canada
GSK Investigational Site
Saint Romuald, Quebec G6W 5M6, Canada
GSK Investigational Site
Sherbrooke, Quebec J1H 4J6, Canada
GSK Investigational Site
Quebec, G1S 2L6, Canada

References and documents

Publications

Silberstein S, Goode-Sellers S, Twomey C, Saiers J, Ascher J. Randomized, double-blind, placebo-controlled, phase II trial of gabapentin enacarbil for migraine prophylaxis. Cephalalgia. 2013 Jan;33(2):101-11. doi: 10.1177/0333102412466968. Epub 2012 Nov 19. PubMed 23165696 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00742209
Lead sponsor: XenoPort, Inc.
Collaborators: GlaxoSmithKline
Responsible party: Sponsor
First posted: Aug 27, 2008
Start date: Aug 2008
Primary completion: Jun 2010
Completion: Jun 2010
Results posted: Dec 5, 2011
Last update: Jul 22, 2013

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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