A Multi-center, Randomized, Double-blind, Parallel Group, Placebo Controlled, Study in Patients With Non-chronic Migraine to Assess the Efficacy, Safety and Tolerability of BID Oral Doses of BGG492 in Migraine Prevention.
| Registry | NCT01617941 |
|---|---|
| Status | Withdrawn |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Sponsor | Novartis Pharmaceuticals (Industry) |
| Conditions | Patients With Migraine Equal of /More Than 3 and Equal of/ Less Than 12 Migraine Attacks/4 Weeks for Each of the Last 6 Months Preceding the Screening |
| Interventions | BGG492, Placebo (Drug) |
| Dates | start 2016-05-01, primary completion 2016-11-01 (estimated), completion 2016-11-01 (estimated), first posted 2012-06-13, last updated 2017-04-20 |
Related Papers Related Patents Related Grants Related Experts
All trials for Patients With Migraine Equal of /More Than 3 and Equal of/ Less Than 12 Migraine Attacks/4 Weeks for Each of the Last 6 Months Preceding the Screening All trials of BGG492 All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| BGG492 | Experimental | Drug: BGG492 | At Baseline 60 patients will be randomized to receive BGG492 for the upcoming 12 weeks (dose: 75 mg BID administered in approx. 12 hours +/- 2 hours intervals). |
| Placebo | Placebo comparator | Drug: Placebo | At Baseline 30 patients will be randomized to receive Placebo for the upcoming 12 weeks (matching a dose of 75 mg BID BGG492 administered in approx. 12 hours +/- 2 hours intervals). |
Sex: All, ages: 18 Years to 55 Years
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