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Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00742209 |
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.
Condition | Intervention | Phase |
---|---|---|
Migraine |
Drug: GSK1838262 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | A Dose-Ranging Study Evaluating Efficacy, Safety and Tolerability of GSK1838262 (XP13512)in the Prophylactic Treatment of Migraine Headache |
Estimated Enrollment: | 450 |
Study Start Date: | August 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
>=3 migraine headache attacks/month and >=6 migraine headache days but less than 15 total headache days (migraine and non-migraine) during 3 months prior to screen;
Exclusion criteria:
Previous use of gabapentin or pregabalin for prophylactic treatment of migraines; history of ergotamine, triptan, opioid and/or combination pain medication use on >= days/month on regular basis for >=3 months
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111381 |
Study First Received: | August 26, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00742209 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
migraine prophylaxis prevention |
Migraine Disorders Headache Central Nervous System Diseases |
Headache Disorders, Primary Brain Diseases Headache Disorders |
Nervous System Diseases |