Prevention Study in Adult Patients Suffering From Migraine Headaches

NCT00742209 | Completed Phase 2 Results

• 1 other identifier: 111381
• Study Type: interventional
• Target: 526
• Locations: 2 countries
• Sites: 59

Brief 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.

Conditions

Migraine Disorders; Migraine

Keywords

migraine; prophylaxis; prevention

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (14)

• Mean Change From Baseline in the Number of MHD in All Study Phases

  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

  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)

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

• Change From Baseline in the Mean Migraine Attack Duration

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

• Change From Baseline in the Mean Peak Migraine Pain Severity

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

Other Outcomes (4)

• 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

  Baseline and Week 17

• Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17

  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)

  Week 17

Study Arms (5)

Placebo

PLACEBO COMPARATOR

PBO

Drug: Placebo

GSK 1838262 1200 mg/day

ACTIVE COMPARATOR

600 or 1200 mg/day

Drug: GSK1838262

GSK 1838262 1800 mg/day

ACTIVE COMPARATOR

600 or 1200 or 1800 mg/day

Drug: GSK1838262

GSK 1838262 2400 mg/day

ACTIVE COMPARATOR

600 or 1200 or 1800 or 2400 mg/day

Drug: GSK1838262

GSK 1838262 3000 mg/day

ACTIVE COMPARATOR

600 or 1200 or 1800 or 2400 or 3000 mg/day

Drug: GSK1838262

Interventions

GSK1838262 DRUG

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

Also known as: XP13512

GSK 1838262 1200 mg/day; GSK 1838262 1800 mg/day; GSK 1838262 2400 mg/day; GSK 1838262 3000 mg/day

Placebo DRUG

Placebo-control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• XenoPort, Inc.: lead
• GlaxoSmithKline: collaborator

Study Sites (59)

GSK Investigational Site

Birmingham, Alabama, 35233, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85016, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85023, United States

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GSK Investigational Site

Anaheim, California, 92801, United States

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GSK Investigational Site

Newport Beach, California, 92660, United States

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GSK Investigational Site

Redlands, California, 92374, United States

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GSK Investigational Site

San Francisco, California, 94109, United States

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GSK Investigational Site

Santa Monica, California, 90404, United States

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GSK Investigational Site

Westlake Village, California, 91361, United States

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GSK Investigational Site

Colorado Springs, Colorado, 80904, United States

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GSK Investigational Site

Colorado Springs, Colorado, 80909, United States

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GSK Investigational Site

Denver, Colorado, 80239, United States

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GSK Investigational Site

DeLand, Florida, 32720, United States

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GSK Investigational Site

Sunrise, Florida, 33351, United States

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GSK Investigational Site

West Palm Beach, Florida, 33407, United States

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GSK Investigational Site

Atlanta, Georgia, 30308, United States

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GSK Investigational Site

Stockbridge, Georgia, 30281, United States

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GSK Investigational Site

Chicago, Illinois, 60642, United States

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GSK Investigational Site

Wichita, Kansas, 67207, United States

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GSK Investigational Site

Kalamazoo, Michigan, 49009, United States

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GSK Investigational Site

Golden Valley, Minnesota, 55422, United States

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GSK Investigational Site

Kansas City, Missouri, 64111, United States

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Springfield, Missouri, 65807, United States

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GSK Investigational Site

St Louis, Missouri, 63141, United States

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GSK Investigational Site

Las Vegas, Nevada, 89119, United States

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Albany, New York, 12206, United States

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GSK Investigational Site

Greensboro, North Carolina, 27405, United States

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GSK Investigational Site

Raleigh, North Carolina, 27607, United States

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GSK Investigational Site

Raleigh, North Carolina, 27609, United States

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GSK Investigational Site

Cleveland, Ohio, 44195, United States

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GSK Investigational Site

West Chester, Ohio, 45069, United States

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GSK Investigational Site

Westerville, Ohio, 43081, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19139, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15236, United States

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GSK Investigational Site

Charleston, South Carolina, 29412, United States

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Memphis, Tennessee, 38018, United States

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GSK Investigational Site

Nashville, Tennessee, 37203, United States

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GSK Investigational Site

Houston, Texas, 77004, United States

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GSK Investigational Site

San Antonio, Texas, 78205, United States

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GSK Investigational Site

Salt Lake City, Utah, 84109, United States

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GSK Investigational Site

Salt Lake City, Utah, 84121, United States

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GSK Investigational Site

Alexandria, Virginia, 22311, United States

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GSK Investigational Site

Seattle, Washington, 98195, United States

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GSK Investigational Site

Wenatchee, Washington, 98801, United States

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GSK Investigational Site

Penticton, British Columbia, V2A 5C8, Canada

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GSK Investigational Site

Surrey, British Columbia, V4H 2H9, Canada

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GSK Investigational Site

Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

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GSK Investigational Site

Brampton, Ontario, L6T 3T1, Canada

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GSK Investigational Site

Greater Sudbury, Ontario, P3E 1H5, Canada

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GSK Investigational Site

Ottawa, Ontario, K1H 1A2, Canada

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GSK Investigational Site

Ottawa, Ontario, K2G 6E2, Canada

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GSK Investigational Site

Toronto, Ontario, M3H 5S4, Canada

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GSK Investigational Site

Toronto, Ontario, M4S 1Y2, Canada

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GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

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GSK Investigational Site

Montreal, Quebec, H2W 1V1, Canada

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GSK Investigational Site

Québec, Quebec, G1S 2L6, Canada

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GSK Investigational Site

Saint Romuald, Quebec, G6W 5M6, Canada

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GSK Investigational Site

Sherbrooke, Quebec, J1H 4J6, Canada

Location

Related Publications (1)

• 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.

  PMID: 23165696 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: XenoPort Call Center
• Organization: XenoPort, Inc.

877-936-6778

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 22, 2013
• Results First Posted: December 5, 2011

Record last verified: 2011-10

Locations

US (45); CA (14)