A Randomized,Double Blind, Placebo Controlled Study to Assess Efficacy,Safety and Tolerability of BGG492 in Migraine Prevention

• Status: Withdrawn
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

It will provide a first evaluation of efficacy, safety and tolerability of BGG492 in patients with non-chronic migraine having more than 3 and less than 12 migraine attacks per 4 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Male and female smoking and non-smoking subjects of 18 to 65 years of age (inclusive)

• Patients diagnosed with non-chronic migraine with or without aura of duration of at least 12 months prior to the study start

• Patient diagnosed with migraine (according to the International Headache Society categories 1.1 and with equal to/more than 3 and equal to/ less than 12 migraine attacks per 4 weeks for each of the last 6 months preceding the Screening

• Patients willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance

Exclusion Criteria:

• Patients diagnosed with basilar, ophthalmoplegic or hemiplegic migraine as shown in the current/past medical history.

• Patients having an experience of non-migraine headaches on more than 6 days per 4 weeks in the past 6 months prior to study start

• Patients receiving regular treatment during the four (4) weeks preceding the Baseline with psychoactive drugs (e.g. hypnotics, benzodiazepines, neuroleptics) except antidepressants (eg. SSRIs, SNRIs, Tri- or Tetracyclics).

• Patients receiving migraine prevention medications during past three (3) months preceding Baseline

• Patients receiving topiramate as migraine prevention medication during past six (6) months preceding Baseline

• Patients receiving metamizole as acute treatment of migraine during past three (3) months preceding Baseline

• Patients using (or having used within four (4) weeks before the treatment start) drug treatments that are potent inhibitors of OATP transporters (e.g. rifampin).

• Any psychiatric condition (e.g., schizophrenia, dementia, bipolar disorder) as shown in the past medical history prior to study start

• Patients with recent (within the last three [3] years prior to study start) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, orthostatic hypotension etc.).

• Pregnant or nursing (lactating) women. Baselines (1 and 2).

• Patients with history of drug or alcohol abuse within the 12 months prior to dosing Other protocol-defined inclusion/exclusion criteria may apply