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Efficacy and Safety of BGG492 in the Treatment of Migraine

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00892203
Enrollment
75
Registered
2009-05-04
Start date
2009-04-30
Completion date
2010-08-31
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine, Headache

Brief summary

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

Interventions

DRUGBGG492
DRUGSumatriptan
DRUGPlacebo

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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/

Design outcomes

Primary

MeasureTime frame
Reduction in migraine pain2 hours

Countries

Germany, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026