Expired Study
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Encino, California 91316


Purpose:

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.


Study summary:

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. The trial consisted of four phases: screening (≤ 3 weeks of initial screening and a 4-week baseline phase); the double-blind treatment phase (24 weeks) in which participants received placebo or erenumab 70 mg or 140 mg daily; the active-treatment phase, in which participants underwent repeat randomization and were assigned to receive 70 mg or 140 mg of erenumab (28 weeks); and a safety follow-up phase (12 weeks).


Criteria:

Inclusion Criteria: - History of migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3) classification - Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3 months prior to screening and during baseline - Headache frequency: < 15 headache days per month on average across the 3 months prior to screening and baseline - Demonstrated at least 80% compliance with the eDiary. Exclusion Criteria: - Older than 50 years of age at migraine onset - History of cluster headache or hemiplegic migraine headache - Unable to differentiate migraine from other headache - No therapeutic response with > 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial - Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase - Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study


NCT ID:

NCT02456740


Primary Contact:

Study Director
MD
Amgen


Backup Contact:

N/A


Location Contact:

Encino, California 91316
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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