Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

Phase 2 Completed 343 enrolled Amgen

RandomizedParallel-groupTriple-blindPrevention

Summary

To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.

Timeline

Start: 2017-09-06
Primary completion: 2018-10-16
Completion: 2019-02-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs AMG 301 210 mg Q4W; p = 0.66; difference in least square mean 0.26 (95% CI -0.88 to 1.40) NCT03238781 ↗

paper No difference between AMG 301 and placebo on any measure of efficacy was observed; PMID 33231489 ↗

Publications

Ashina M, Dolezil D, Bonner JH, Zhou L, Klatt J, Picard H, Mikol DD. A phase 2, randomized, double-blind, placebo-controlled trial of AMG 301, a pituitary adenylate cyclase-activating polypeptide PAC1 receptor monoclonal antibody for migraine prevention. Cephalalgia. 2021 Jan;41(1):33-44. doi: 10.1177/0333102420970889. Epub 2020 Nov 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AMG 301	Monoclonal antibody	210 mg	Subcutaneous
Subject	AMG 301	Monoclonal antibody	420 mg	Subcutaneous