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Efficacy and Safety of BGG492 in the Treatment of Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00892203
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE May 1, 2009
First Posted Date  ICMJE May 4, 2009
Last Update Posted Date December 17, 2020
Study Start Date  ICMJE April 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2009)
Reduction in migraine pain [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: BGG492
  • Drug: Sumatriptan
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Active
    Intervention: Drug: BGG492
  • Active Comparator: Comparator
    Intervention: Drug: Sumatriptan
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Gomez-Mancilla B, Brand R, Jürgens TP, Göbel 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2009)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00892203
Other Study ID Numbers  ICMJE CBGG492A2204
2008-005392-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Investigator Site
PRS Account Novartis
Verification Date March 2016

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