drugset / Trial / NCT02397473
A Study Of Galcanezumab In Participants With Episodic Cluster Headache
RandomizedParallel-groupDouble-blindTreatment
Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.
Timeline
- Start
- 2015-05-22
- Primary completion
- 2018-02-12
- Completion
- 2018-06-04
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Galcanezumab 300mg; p = 0.036; LSMean Difference -3.47 (95% CI -6.72 to -0.23); Mixed Models Analysis NCT02397473 ↗
release “galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headache” lilly.com ↗
Publications
- Jensen RH, Tassorelli C, Myers Oakes TM, Bardos JN, Zhou C, Dong Y, Aurora SK, Martinez JM. Baseline demographics and disease characteristics of patients with episodic or chronic cluster headache: data from two phase 3 randomized clinical trials in Europe and North America. Front Neurol. 2023 Dec 15;14:1293163. doi: 10.3389/fneur.2023.1293163. eCollection 2023.
- Andrews JS, Kudrow D, Rettiganti M, Oakes T, Bardos JN, Wenzel R, Kuruppu DK, Gaul C, Martinez JM. Impact of Galcanezumab on Total Pain Burden: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Episodic Cluster Headache. J Pain Res. 2021 Jul 8;14:2059-2070. doi: 10.2147/JPR.S305066. eCollection 2021.
- Goadsby PJ, Dodick DW, Leone M, Bardos JN, Oakes TM, Millen BA, Zhou C, Dowsett SA, Aurora SK, Ahn AH, Yang JY, Conley RR, Martinez JM. Trial of Galcanezumab in Prevention of Episodic Cluster Headache. N Engl J Med. 2019 Jul 11;381(2):132-141. doi: 10.1056/NEJMoa1813440.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Galcanezumab | Monoclonal antibody | 300 mg | Subcutaneous |