Efficacy and Safety of BGG492 in the Treatment of Migraine - Tabular View

Tracking Information

First Received Date ^ICMJE

May 1, 2009

Last Updated Date

May 1, 2009

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction in migraine pain [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of BGG492 in the Treatment of Migraine

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: BGG492
Drug: Sumatriptan
Drug: Placebo

Study Arms / Comparison Groups

Active: Experimental
Intervention: Drug: BGG492
Comparator: Active Comparator
Intervention: Drug: Sumatriptan
Placebo: Placebo Comparator
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00892203

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CBGG492A2204, 2008-005392-10

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Novartis Investigator Site

Information Provided By

Novartis

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP