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NCT00892203 Clinical Trial

Efficacy and Safety of BGG492 in the Treatment of Migraine

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00892203
Other study ID # CBGG492A2204
Secondary ID 2008-005392-10
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2009
Est. completion date August 2010

Study information
Verified date March 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• BGG492

• Sumatriptan

• Placebo

Locations
Country Name City State
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Goettingen
Germany Novartis Investigator Site Hamburg
Germany Novartis Investigative Site Kiel
Germany Novartis Investigative Site Koenigstein
Germany Novartis Investigative Site Muenster
Germany Novartis Investigative Site Munich
Germany Novartis Investigator Site Munich
Germany Novartis Investigative Site Wurzburg
Spain Novartis Investigative Site Barcelona
United States California Clinical Trials, 1560 Chevy Chase Drive, Suite 140 Glendale California
United States California Clinical Trials, 15625 Lakewood Boulevard Paramount California

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in migraine pain 2 hours
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