drugset / Trial / NCT03303092
Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 (monthly TEV-48125 225 mg and TEV-48125 675 mg once over a period of 3 months) compared with placebo for preventive treatment in Episodic Migraine patients
Timeline
- Start
- 2017-12-19
- Primary completion
- 2019-11-22
- Completion
- 2019-11-22
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.
- Takeshima T, Nakai M, Shibasaki Y, Ishida M, Kim BK, Ning X, Koga N. Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients. J Headache Pain. 2022 Feb 9;23(1):24. doi: 10.1186/s10194-022-01393-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fremanezumab | Monoclonal antibody | 225 mg | Subcutaneous |
| Subject | Fremanezumab | Monoclonal antibody | 675 mg | Subcutaneous |