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

Amgen

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Erenumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02456740

2014-004464-38 (EudraCT Number)

20120296

Details and patient eligibility

About

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.

Full 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).

Enrollment: 955 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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955 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo once a month (QM) by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.

Treatment:

Drug: Placebo

Erenumab 70 mg QM

Experimental group

Description:

Participants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.

Treatment:

Drug: Erenumab

Erenumab 140 mg QM

Experimental group

Description:

Participants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.

Treatment:

Drug: Erenumab