Efficacy and Safety of BGG492 in the Treatment of Migraine

December 11, 2020 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Essen, Germany
        • Novartis Investigative Site
      • Goettingen, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigator Site
      • Kiel, Germany
        • Novartis Investigative Site
      • Koenigstein, Germany
        • Novartis Investigative Site
      • Muenster, Germany
        • Novartis Investigative Site
      • Munich, Germany
        • Novartis Investigative Site
      • Munich, Germany
        • Novartis Investigator Site
      • Wurzburg, Germany
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
  • United States
    • California
      • Glendale, California, United States, 91206
        • California Clinical Trials, 1560 Chevy Chase Drive, Suite 140
      • Paramount, California, United States, 90723
        • California Clinical Trials, 15625 Lakewood Boulevard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Comparator
Drug: Sumatriptan
Experimental: Active
Drug: BGG492

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in migraine pain
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Investigator Site

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

May 1, 2009

First Submitted That Met QC Criteria

May 1, 2009

First Posted (Estimate)

May 4, 2009

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBGG492A2204
  • 2008-005392-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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