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Clinical trial

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention (STRIVE)

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Last updated:11th Oct 2022
Status: Completed
Identifier: NCT02456740
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention (STRIVE)


Brief Summary:

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.

Detailed Description:
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).


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 955 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Actual Study Start Date: July 17, 2015
Actual Primary Completion Date: September 5, 2016
Actual Study Completion Date: June 19, 2017

Arm:
- Placebo Comparator:
Placebo
- Experimental: Erenumab 70 mg QM
- Experimental: Erenumab 140 mg QM

Category Value
Study type(s) Interventional
Expected enrolment 955
Study start date 17 July 2015
Estimated primary completion date 19 June 2017

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