drugset / Trial / NCT02959177
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine
RandomizedParallel-groupDouble-blindTreatment
Summary
The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in Japanese participants with episodic migraine.
Timeline
- Start
- 2016-11-09
- Primary completion
- 2019-01-18
- Completion
- 2019-01-18
Outcome
Met primary endpoint
registry analysis (superiority test); 120 mg Galcanezumab vs Placebo; p <0.001; LSMean Difference -3.01 (95% CI -3.80 to -2.22); Mixed Models Analysis NCT02959177 ↗
registry analysis (superiority test); 240 mg Galcanezumab vs Placebo; p <0.001; Mean Difference (Final Values) -2.7 (95% CI -3.53 to -1.94); Mixed Models Analysis NCT02959177 ↗
Publications
- Takeshima T, Doi H, Ooba S, Tanji Y, Ozeki A, Komori M. Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine: Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study. Neurol Ther. 2024 Jun;13(3):697-714. doi: 10.1007/s40120-024-00602-z. Epub 2024 Apr 6.
- Shibata M, Nihira A, Tanji Y, Ozeki A, Imagawa H, Komori M. Galcanezumab Efficacy Through the Dosing Interval in Japanese Patients with Episodic Migraine: Post Hoc Analysis of a Phase 2 Randomized Trial. Neurol Ther. 2023 Dec;12(6):2007-2019. doi: 10.1007/s40120-023-00534-0. Epub 2023 Sep 12.
- Igarashi H, Shibata M, Ozeki A, Matsumura T. Galcanezumab Effects on Migraine Severity and Symptoms in Japanese Patients with Episodic Migraine: Secondary Analysis of a Phase 2 Randomized Trial. Neurol Ther. 2023 Feb;12(1):73-87. doi: 10.1007/s40120-022-00410-3. Epub 2022 Oct 20.
- Igarashi H, Shibata M, Ozeki A, Day KA, Matsumura T. Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine. J Pain Res. 2021 Nov 16;14:3555-3564. doi: 10.2147/JPR.S326905. eCollection 2021.
- Tatsuoka Y, Takeshima T, Ozeki A, Matsumura T. Treatment Satisfaction of Galcanezumab in Japanese Patients with Episodic Migraine: A Phase 2 Randomized Controlled Study. Neurol Ther. 2021 Jun;10(1):265-278. doi: 10.1007/s40120-021-00236-5. Epub 2021 Apr 9.
- Shibata M, Nakamura T, Ozeki A, Ueda K, Nichols RM. Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Score Improvement in Japanese Patients with Episodic Migraine by Galcanezumab Treatment: Japan Phase 2 Study. J Pain Res. 2020 Dec 31;13:3531-3538. doi: 10.2147/JPR.S287781. eCollection 2020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Galcanezumab | Monoclonal antibody | 120 mg | Subcutaneous |
| Subject | Galcanezumab | Monoclonal antibody | 240 mg | Subcutaneous |