A Randomized,Double Blind, Placebo Controlled Study to Assess Efficacy,Safety and Tolerability of BGG492 in Migraine Prevention
Phase 2
Withdrawn
- 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
- Drug: Placebo
- Registration Number
- NCT01617941
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BGG492 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 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).
- Primary Outcome Measures
Name Time Method Frequency of migraine attacks 12 weeks 50% responder rate (equal to or more than 50 % reduction in attack frequency during the last 4-weeks of the 12-weeks treatment period compared with the 4-weeks Baseline period)
- Secondary Outcome Measures
Name Time Method Number of migraine attacks 12 weeks Mean change in number of migraine attacks comparing the last 4-weeks treatment with the Baseline period.