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Efficacy and Safety of BGG492 in the Treatment of Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BGG492
Sumatriptan
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Headache

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Clinical Trials, 1560 Chevy Chase Drive, Suite 140
  • California Clinical Trials, 15625 Lakewood Boulevard
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Active

Comparator

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Reduction in migraine pain

Secondary Outcome Measures

Full Information

First Posted
May 1, 2009
Last Updated
December 11, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00892203
Brief Title
Efficacy and Safety of BGG492 in the Treatment of Migraine
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Title
Comparator
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BGG492
Intervention Type
Drug
Intervention Name(s)
Sumatriptan
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Reduction in migraine pain
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 Smokers Patients with a very high or low body weight Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Investigator Site
Official's Role
Study Director
Facility Information:
Facility Name
California Clinical Trials, 1560 Chevy Chase Drive, Suite 140
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
California Clinical Trials, 15625 Lakewood Boulevard
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
Country
Germany
Facility Name
Novartis Investigative Site
City
Goettingen
Country
Germany
Facility Name
Novartis Investigator Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
Country
Germany
Facility Name
Novartis Investigative Site
City
Koenigstein
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
Country
Germany
Facility Name
Novartis Investigative Site
City
Munich
Country
Germany
Facility Name
Novartis Investigator Site
City
Munich
Country
Germany
Facility Name
Novartis Investigative Site
City
Wurzburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23963355
Citation
Gomez-Mancilla B, Brand R, Jurgens TP, Gobel H, Sommer C, Straube A, Evers S, Sommer M, Campos V, Kalkman HO, Hariry S, Pezous N, Johns D, Diener HC; BGG492 Study Group. Randomized, multicenter trial to assess the efficacy, safety and tolerability of a single dose of a novel AMPA receptor antagonist BGG492 for the treatment of acute migraine attacks. Cephalalgia. 2014 Feb;34(2):103-13. doi: 10.1177/0333102413499648. Epub 2013 Aug 20.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5409
Description
Results for CBGG492A2204 from the Novartis Clinical Trials website

Learn more about this trial

Efficacy and Safety of BGG492 in the Treatment of Migraine

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