A Randomized,Double Blind, Placebo Controlled Study to Assess Efficacy,Safety and Tolerability of BGG492 in Migraine Prevention
|ClinicalTrials.gov Identifier: NCT01617941|
Recruitment Status : Withdrawn
First Posted : June 13, 2012
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: BGG492 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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.|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2016|
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).
Placebo Comparator: 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).
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.
- 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)
- Number of migraine attacks [ Time Frame: 12 weeks ]Mean change in number of migraine attacks comparing the last 4-weeks treatment with the Baseline period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617941
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|