Efficacy and Safety of BGG492 in the Treatment of Migraine

This study has been completed.

First Received on May 1, 2009. Last Updated on May 4, 2012 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00892203

Purpose

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: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Headache Migraine

Drug Information available for: Sumatriptan Sumatriptan succinate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Reduction in migraine pain [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892203

Locations

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
Germany
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 Investigator Site
Munich, Germany
Novartis Investigative Site
Munich, Germany
Novartis Investigative Site
Wurzburg, Germany
Spain
Novartis Investigative Site
Barcelona, Spain

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

Novartis Investigator Site

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00892203 History of Changes
Other Study ID Numbers:	CBGG492A2204, 2008-005392-10
Study First Received:	May 1, 2009
Last Updated:	May 4, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines

Keywords provided by Novartis:

Migraine
Headache

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012