NCT01617941
Withdrawn
Phase 2
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.
Overview
- Phase
- Phase 2
- Intervention
- BGG492
- 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
- Sponsor
- Novartis Pharmaceuticals
- Primary Endpoint
- Frequency of migraine attacks
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility 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).
Arms & Interventions
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).
Intervention: BGG492
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).
Intervention: Placebo
Outcomes
Primary Outcomes
Frequency of migraine attacks
Time Frame: 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 Outcomes
- Number of migraine attacks(12 weeks)
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