Efficacy and Safety of BGG492 in the Treatment of Migraine

Novartis

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: BGG492; Drug: Placebo; Drug: Sumatriptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00892203

CBGG492A2204

2008-005392-10 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

Active

Experimental group

Treatment:

Drug: BGG492

Comparator

Active Comparator group

Treatment:

Drug: Sumatriptan

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo