NCT00892203
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- BGG492
- Conditions
- Migraine
- Sponsor
- Novartis
- Enrollment
- 75
- Locations
- 4
- Primary Endpoint
- Reduction in migraine pain
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study will assess the efficacy and safety of BGG492 used to treat migraine pain.
Investigators
Eligibility 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
- •Patients with a very high or low body weight Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
Active
Intervention: BGG492
Comparator
Intervention: Sumatriptan
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Reduction in migraine pain
Time Frame: 2 hours
Study Sites (4)
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