Efficacy and Safety of BGG492 in the Treatment of Migraine
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: BGG492 (Drug); Sumatriptan (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Investigator Site
Summary
This study will assess the efficacy and safety of BGG492 used to treat migraine pain.
Clinical Details
Official title: A Multi-Centre, Randomized, Double-Blind, Parallel Group, Active and Placebo Controlled, Proof of Concept Study in Patients With Acute Migraine to Assess the Efficacy, Safety and Tolerability of Single Oral Doses of BGG492
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Reduction in migraine pain
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of moderate to severe migraine for at least 1 year
- At least 1 migraine episode, but not more 15 migraine days per month
- Past use of triptans
- Migraine onset before 50 years of age
Exclusion Criteria:
- Diagnosis of basilar, ophthalmoplegic or hemiplegic migraine.
- More than 6 non-migraine headaches per month
- Patients receiving migraine prophylaxis treatment
- Patients receiving regular treatment with psychoactive drugs
- Smokers
- Patients with a very high or low body weight Other protocol-defined
inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Investigative Site, Essen, Germany; Recruiting
Novartis, Phone: +41-61-324-1111
Novartis Investigator Site, Munich, Germany; Recruiting
Novartis, Phone: +41-61-324-1111
Novartis Investigator Site, Hamburg, Germany; Recruiting
Novartis, Phone: +41-61-324-1111
Novartis Investigative Site, Kiel, Germany; Recruiting
Novartis, Phone: +41-61-324-1111
Additional Information
Starting date: April 2009
Last updated: May 1, 2009
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