Prevention Study in Adult Patients Suffering From Migraine Headaches - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00742209

Purpose

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

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline in the number of migraine headache days during the last 4 weeks of treatment prior to taper

Secondary Outcome Measures:

Change from baseline in: the number of migraine headache days for various study phases; the number of migraine attacks; the number of migraine headache periods; mean migraine attack duration; the mean peak migraine pain severity

Estimated Enrollment:	450
Study Start Date:	August 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742209

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 91 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

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

Keywords provided by GlaxoSmithKline:

migraine
prophylaxis
prevention

Study placed in the following topic categories:

Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009