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

NCT01617941 | Withdrawn Phase 2

• 2 other identifiers: CBGG492A22142011-005316-28
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

non-chronic migraine, migraine prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of migraine attacks

  12 weeks

Study Arms (2)

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

Interventions

BGG492 DRUG

BGG492

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Interventions

selurampanel

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2012
• First Posted: June 13, 2012
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 20, 2017

Record last verified: 2014-09