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Efficacy and Safety of BGG492 in the Treatment of Migraine

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: May 1, 2009
Last updated: March 28, 2016
Last verified: March 2016
This study will assess the efficacy and safety of BGG492 used to treat migraine pain.

Condition Intervention Phase
Migraine Drug: BGG492 Drug: Sumatriptan Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

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

Enrollment: 75
Study Start Date: April 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: BGG492
Active Comparator: Comparator Drug: Sumatriptan
Placebo Comparator: Placebo Drug: Placebo


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00892203

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
Study Director: Novartis Pharmaceuticals Novartis Investigator Site
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00892203     History of Changes
Other Study ID Numbers: CBGG492A2204
2008-005392-10 ( EudraCT Number )
Study First Received: May 1, 2009
Last Updated: March 28, 2016

Keywords provided by Novartis:

Additional relevant MeSH terms:
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 processed this record on September 21, 2017