Prevention Study in Adult Patients Suffering From Migraine Headaches
NCT00742209 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 526
Last updated 2013-07-22
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
Interventions
- DRUG
-
GSK1838262
Flexible dosing: 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day
- DRUG
-
Placebo-control
Sponsors & Collaborators
- collaborator INDUSTRY
-
XenoPort, Inc.
lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-08-31
- Primary Completion
- 2010-06-30
- Completion
- 2010-06-30
Countries
- United States
- Canada
Study Locations
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