Efficacy and Safety of BGG492 in the Treatment of Migraine | NCT00892203

Studies
Efficacy and Safety of BGG492 in the Treatment of Migraine

NCT00892203

Sponsor

Novartis

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

75Actual

Phase

Phase 2

Conditions

Migraine

Interventions

BGG492
Sumatriptan
Placebo

Countries

United States
Germany
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-005392-10	EudraCT Number

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

May 1, 2009

First Submission Date that Met QC Criteria

May 1, 2009

First Posted Date

May 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Mar 28, 2016

Certification/Extension First Submitted that Passed QC Review

Mar 28, 2016

Certification/Extension First Posted Date

May 2, 2016Estimated

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Active	Experimental	Drug: BGG492
Comparator	Active Comparator	Drug: Sumatriptan
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BGG492	Drug		Active
Sumatriptan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in migraine pain		2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Investigator Site	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
California Clinical Trials, 1560 Chevy Chase Drive, Suite 140		Glendale	California	91206	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23963355	Derived	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.

ID	Term
D008881	Migraine Disorders
D006261	Headache

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
C000591013	selurampanel
D018170	Sumatriptan

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457