Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine

Summary

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with episodic migraine

Timeline

Start

2016-03-23

Primary completion

2017-04-10

Completion

2017-04-10

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Fremanezumab 675 mg/Placebo/Placebo; p <0.0001; Wilcoxon (Mann-Whitney); note: 0.05 level of significance NCT02629861 ↗

registry analysis (superiority test); Placebo vs Fremanezumab 225/225/225 mg; p <0.0001; Wilcoxon (Mann-Whitney); note: 0.05 level of significance NCT02629861 ↗

release “In the episodic migraine (EM) study, patients treated with monthly and quarterly fremanezumab experienced clinically and statistically significant improvements in all endpoints” tevapharm.com ↗

release “The HALO EM trial met its primary endpoint demonstrating that fremanezumab significantly reduced monthly migraine days for both quarterly and monthly dosing regimens” tevapharm.com ↗

Publications

• Tatsumoto M, Ishida M, Iba K, Kim BK, Ning X, Osawa C, Nakai M, Kurita Y. Effects of fremanezumab on migraine-associated symptoms and medication use in Japanese and Korean patients with episodic migraine: Exploratory endpoint analysis of a multicenter, randomized, double-blind, placebo-controlled trial. Headache. 2025 Mar;65(3):399-406. doi: 10.1111/head.14810. Epub 2024 Sep 2.
• McAllister P, Cohen JM, Campos VR, Ning X, Janka L, Barash S. Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. J Headache Pain. 2022 Aug 29;23(1):112. doi: 10.1186/s10194-022-01438-4.
• Diener HC, McAllister P, Jurgens TP, Kessler Y, Ning X, Cohen JM, Campos VR, Barash S, Silberstein SD. Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. Cephalalgia. 2022 Jul;42(8):769-780. doi: 10.1177/03331024221076485. Epub 2022 Mar 25.
• Nahas SJ, Naegel S, Cohen JM, Ning X, Janka L, Campos VR, Krasenbaum LJ, Holle-Lee D, Kudrow D, Lampl C. Efficacy and safety of fremanezumab in clinical trial participants aged >/=60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies. J Headache Pain. 2021 Nov 24;22(1):141. doi: 10.1186/s10194-021-01351-2.
• Silberstein SD, Cohen JM, Yang R, Gandhi SK, Du E, Jann AE, Marmura MJ. Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials. J Headache Pain. 2021 Jan 7;22(1):2. doi: 10.1186/s10194-020-01212-4.
• Brandes JL, Kudrow D, Yeung PP, Sakai F, Aycardi E, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia. 2020 Apr;40(5):470-477. doi: 10.1177/0333102419885905. Epub 2019 Nov 21.
• Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018 May 15;319(19):1999-2008. doi: 10.1001/jama.2018.4853.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fremanezumab	Monoclonal antibody	225 mg	Subcutaneous
Subject	Fremanezumab	Monoclonal antibody	675 mg	Subcutaneous

Indications