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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. Identifier: NCT00892203
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : December 17, 2020
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Migraine Drug: BGG492 Drug: Sumatriptan Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Active Drug: BGG492
Active Comparator: Comparator Drug: Sumatriptan
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Reduction in migraine pain [ Time Frame: 2 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00892203

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United States, California
California Clinical Trials, 1560 Chevy Chase Drive, Suite 140
Glendale, California, United States, 91206
California Clinical Trials, 15625 Lakewood Boulevard
Paramount, California, United States, 90723
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Goettingen, Germany
Novartis Investigator Site
Hamburg, Germany
Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Koenigstein, Germany
Novartis Investigative Site
Muenster, Germany
Novartis Investigative Site
Munich, Germany
Novartis Investigator Site
Munich, Germany
Novartis Investigative Site
Wurzburg, Germany
Novartis Investigative Site
Barcelona, Spain
Sponsors and Collaborators
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Study Director: Novartis Pharmaceuticals Novartis Investigator Site
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Identifier: NCT00892203    
Other Study ID Numbers: CBGG492A2204
2008-005392-10 ( EudraCT Number )
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: March 2016
Keywords provided by Novartis:
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs