Efficacy and Safety of BGG492 in the Treatment of Migraine

NCT ID: NCT00892203

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Group Type EXPERIMENTAL

BGG492

Intervention Type DRUG

Comparator

Group Type ACTIVE_COMPARATOR

Sumatriptan

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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BGG492

Intervention Type DRUG

Sumatriptan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Investigator Site

Locations

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California Clinical Trials, 1560 Chevy Chase Drive, Suite 140

Glendale, California, United States

Site Status

California Clinical Trials, 15625 Lakewood Boulevard

Paramount, California, United States

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Göttingen, , Germany

Site Status

Novartis Investigator Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Kiel, , Germany

Site Status

Novartis Investigative Site

Königstein, , Germany

Site Status

Novartis Investigative Site

Munich, , Germany

Site Status

Novartis Investigator Site

Munich, , Germany

Site Status

Novartis Investigative Site

Münster, , Germany

Site Status

Novartis Investigative Site

Würzburg, , Germany

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Countries

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United States Germany Spain

References

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Gomez-Mancilla B, Brand R, Jurgens TP, Gobel 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.

Reference Type DERIVED
PMID: 23963355 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5409

Results for CBGG492A2204 from the Novartis Clinical Trials website

Other Identifiers

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2008-005392-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBGG492A2204

Identifier Type: -

Identifier Source: org_study_id

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