Efficacy and Safety of BGG492 in the Treatment of Migraine

This study is currently recruiting participants.

Verified by Novartis, May 2009

First Received: May 1, 2009 No Changes Posted

Sponsored by:	Novartis
Information provided by:	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 II

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Sumatriptan Sumatriptan succinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Estimated Enrollment:	75
Study Start Date:	April 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental	Drug: BGG492
Comparator: Active Comparator	Drug: Sumatriptan
Placebo: Placebo Comparator	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

Germany
Novartis Investigative Site	Recruiting
Essen, Germany
Contact: Novartis +41-61-324-1111
Novartis Investigator Site	Recruiting
Munich, Germany
Contact: Novartis +41-61-324-1111
Novartis Investigator Site	Recruiting
Hamburg, Germany
Contact: Novartis +41-61-324-1111
Novartis Investigative Site	Recruiting
Kiel, Germany
Contact: Novartis +41-61-324-1111

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

Novartis Investigator Site

More Information

No publications provided

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

Keywords provided by Novartis:

Migraine
Headache

Study placed in the following topic categories:

Serotonin Agonists
Sumatriptan
Neurotransmitter Agents
Migraine Disorders
Headache
Vasoconstrictor Agents

Central Nervous System Diseases
Headache Disorders, Primary
Cardiovascular Agents
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Cardiovascular Agents

Brain Diseases
Pharmacologic Actions
Headache Disorders
Sumatriptan
Serotonin Agents
Migraine Disorders
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on May 07, 2009