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

Novartis

Status and phase: Withdrawn; Phase 2

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

Treatments: Drug: Placebo; Drug: BGG492

Study type: Interventional

Funder types: Industry

Identifiers

NCT01617941

2011-005316-28 (EudraCT Number)

CBGG492A2214

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

BGG492

Experimental group

Description:

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).

Treatment:

Drug: BGG492

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo