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

NCT ID: NCT01617941

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-11-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

BGG492

Intervention Type: 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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

In patients not tolerating a dose of 75 mg BID BGG492/Placebo the dose can be decreased to 50 mg BID and this dose will be continued for the rest of the planned treatment. Those patients who are not tolerating 50 mg BID BGG492/Placebo will be discontinued from the trial.

Interventions

BGG492

Intervention Type: DRUG

Placebo

In patients not tolerating a dose of 75 mg BID BGG492/Placebo the dose can be decreased to 50 mg BID and this dose will be continued for the rest of the planned treatment. Those patients who are not tolerating 50 mg BID BGG492/Placebo will be discontinued from the trial.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

2011-005316-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBGG492A2214

Identifier Type: -

Identifier Source: org_study_id