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Migraine DisordersPhase 2NCT00742209

Prevention Study in Adult Patients Suffering From Migraine Headaches

A Phase 2 study testing GSK1838262 in people with Migraine Disorders and Migraine, run by XenoPort, Inc. at 59 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine Disorders, Migraine
What is being tested?
GSK1838262
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
526 participants
Where
59 sitesin 2 countries
Study dates
Aug 2008to Jun 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 30Show fewer
  • 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.

Trial locations and contacts

59 sites in 2 countries.

59 sites in 2 countries

United States45 sites

  • GSK Investigational Site

    Albany, New York, 12206

  • GSK Investigational Site

    Alexandria, Virginia, 22311

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Atlanta, Georgia, 30308

  • GSK Investigational Site

    Birmingham, Alabama, 35233

  • GSK Investigational Site

    Charleston, South Carolina, 29412

  • GSK Investigational Site

    Chicago, Illinois, 60642

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Colorado Springs, Colorado, 80904

  • GSK Investigational Site

    Colorado Springs, Colorado, 80909

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Denver, Colorado, 80239

  • GSK Investigational Site

    Golden Valley, Minnesota, 55422

  • GSK Investigational Site

    Greensboro, North Carolina, 27405

  • GSK Investigational Site

    Houston, Texas, 77004

  • GSK Investigational Site

    Kalamazoo, Michigan, 49009

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Memphis, Tennessee, 38018

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Newport Beach, California, 92660

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19139

  • GSK Investigational Site

    Phoenix, Arizona, 85016

  • GSK Investigational Site

    Phoenix, Arizona, 85023

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15236

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Redlands, California, 92374

  • GSK Investigational Site

    Salt Lake City, Utah, 84109

  • GSK Investigational Site

    Salt Lake City, Utah, 84121

  • GSK Investigational Site

    San Antonio, Texas, 78205

  • GSK Investigational Site

    San Francisco, California, 94109

  • GSK Investigational Site

    Santa Monica, California, 90404

  • GSK Investigational Site

    Seattle, Washington, 98195

  • GSK Investigational Site

    Springfield, Missouri, 65807

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stockbridge, Georgia, 30281

  • GSK Investigational Site

    Sunrise, Florida, 33351

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    West Chester, Ohio, 45069

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    Westerville, Ohio, 43081

  • GSK Investigational Site

    Westlake Village, California, 91361

  • GSK Investigational Site

    Wichita, Kansas, 67207

Other trials in United States

Canada14 sites

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Brampton, Ontario, L6T 3T1

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    Montreal, Quebec, H2W 1V1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 1A2

  • GSK Investigational Site

    Ottawa, Ontario, K2G 6E2

  • GSK Investigational Site

    Penticton, British Columbia, V2A 5C8

  • GSK Investigational Site

    Québec, Quebec, G1S 2L6

  • GSK Investigational Site

    Saint Romuald, Quebec, G6W 5M6

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 4J6

  • GSK Investigational Site

    Surrey, British Columbia, V4H 2H9

  • GSK Investigational Site

    Toronto, Ontario, M3H 5S4

  • GSK Investigational Site

    Toronto, Ontario, M4S 1Y2

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

About this study

Official title: Study MPX111381: A Dose-ranging Study Evaluating the Efficacy, Safety and Tolerability of GSK1838262 (XP13512) in the Prophylactic Treatment of Migraine Headache

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.

Being tested
GSK1838262, Placebo
Keywords
migraine, prophylaxis, prevention
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK1838262Drug

    Also called XP13512

    Flexible dosing: 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day

  • PlaceboDrug

    Placebo-control

Study groups in NCT00742209
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPBO
Receives: Drug: Placebo
GSK 1838262 1200 mg/dayActive comparator600 or 1200 mg/day
Receives: Drug: GSK1838262
GSK 1838262 1800 mg/dayActive comparator600 or 1200 or 1800 mg/day
Receives: Drug: GSK1838262
GSK 1838262 2400 mg/dayActive comparator600 or 1200 or 1800 or 2400 mg/day
Receives: Drug: GSK1838262
GSK 1838262 3000 mg/dayActive comparator600 or 1200 or 1800 or 2400 or 3000 mg/day
Receives: Drug: GSK1838262

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Secondary outcomes (14)

  1. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  2. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  3. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  4. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  5. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  6. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  7. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  8. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  9. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  10. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  11. 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.

    Measured: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

  12. 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.

    Measured: Baseline to the Last 4 weeks of treatment

  13. 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."

    Measured: Week 17

  14. 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'.

    Measured: Week 17

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00742209
Sponsor's protocol ID
111381
Status last verified
Oct 2011
First submitted
26 Aug 2008
Last updated
22 Jul 2013
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK1838262 in people with Migraine Disorders and Migraine, run by XenoPort, Inc. at 59 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper (time frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00742209, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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