Efficacy and Safety of BGG492 in the Treatment of Migraine

Phase 2

Completed

• Conditions: Migraine
• Interventions: Drug: BGG492; Drug: Sumatriptan; Drug: Placebo

• Registration Number: NCT00892203
• Lead Sponsor: Novartis

Brief Summary

This study will assess the efficacy and safety of BGG492 used to treat migraine pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-01
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-04
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2016-03
• Disposition First Submitted: 2016-03-28
• Disposition First Submitted QC: 2016-03-28
• Disposition First Posted: 2016-05-02
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	BGG492	-
Comparator	Sumatriptan	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Reduction in migraine pain	2 hours

Trial Locations

Locations (4)

California Clinical Trials, 1560 Chevy Chase Drive, Suite 140; 🇺🇸 Glendale, California, United States

California Clinical Trials, 15625 Lakewood Boulevard; 🇺🇸 Paramount, California, United States

Novartis Investigative Site; 🇪🇸 Barcelona, Spain

Novartis Investigator Site; 🇩🇪 Munich, Germany