A Randomized,Double Blind, Placebo Controlled Study to As... | NCT01617941

ID	Type	Description	Link
2011-005316-28	EudraCT Number

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BGG492	Experimental	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).	Drug: BGG492
Placebo	Placebo Comparator	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).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BGG492	Drug		BGG492
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of migraine attacks	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)	12 weeks

Measure	Description	Time Frame
Number of migraine attacks	Mean change in number of migraine attacks comparing the last 4-weeks treatment with the Baseline period.	12 weeks

Eligibility Module

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