drugset / Trial / NCT00883051
Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.
Timeline
- Start
- 2009-07
- Primary completion
- 2010-02
- Completion
- 2010-02
Outcome
Met primary endpoint
paper There was a linear association between headache response rate at 2 h and lasmiditan dose (Cochran-Armitage test p<0·0001). PMID 22459549 ↗
paper Every lasmiditan treatment dose significantly improved headache response at 2 h compared with placebo PMID 22459549 ↗
Publications
- Blumenfeld A, Tepper SJ, Khanna R, Doty E, Vincent M, Miller SI. Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience. Front Neurol. 2023 Oct 27;14:1291102. doi: 10.3389/fneur.2023.1291102. eCollection 2023.
- Farkkila M, Diener HC, Geraud G, Lainez M, Schoenen J, Harner N, Pilgrim A, Reuter U; COL MIG-202 study group. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012 May;11(5):405-13. doi: 10.1016/S1474-4422(12)70047-9. Epub 2012 Mar 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lasmiditan | Small molecule | 50 mg | Oral |
| Subject | Lasmiditan | Small molecule | 100 mg | Oral |
| Subject | Lasmiditan | Small molecule | 200 mg | Oral |
| Subject | Lasmiditan | Small molecule | 400 mg | Oral |