Efficacy and Safety of BGG492 in the Treatment of Migraine
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
2 other identifiers
interventional
75
3 countries
13
Brief Summary
This study will assess the efficacy and safety of BGG492 used to treat migraine pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2009
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 1, 2009
CompletedFirst Posted
Study publicly available on registry
May 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedDecember 17, 2020
March 1, 2016
1.3 years
May 1, 2009
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in migraine pain
2 hours
Study Arms (3)
Active
EXPERIMENTALComparator
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (13)
California Clinical Trials, 1560 Chevy Chase Drive, Suite 140
Glendale, California, 91206, United States
California Clinical Trials, 15625 Lakewood Boulevard
Paramount, California, 90723, United States
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Göttingen, Germany
Novartis Investigator Site
Hamburg, Germany
Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Königstein, Germany
Novartis Investigative Site
Munich, Germany
Novartis Investigator Site
Munich, Germany
Novartis Investigative Site
Münster, Germany
Novartis Investigative Site
Würzburg, Germany
Novartis Investigative Site
Barcelona, Spain
Related Publications (1)
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.
PMID: 23963355DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Investigator Site
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2009
First Posted
May 4, 2009
Study Start
April 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
December 17, 2020
Record last verified: 2016-03