drugset / Trial / NCT00623636
Phase 3 Study of MAP0004 in Adult Migraineurs
Phase 3
Completed
902 enrolled
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.
Timeline
- Start
- 2008-07
- Primary completion
- 2010-12
- Completion
- 2011-01
Outcome
Met primary endpoint
paper MAP0004 was superior to placebo in all 4 co-primary endpoints: PMID 21457235 ↗
paper pain relief (58.7% vs 34.5%, P < .0001) PMID 21457235 ↗
paper phonophobia free (52.9% vs 33.8%, P < .0001) PMID 21457235 ↗
paper photophobia free (46.6% vs 27.2%, P < .0001) PMID 21457235 ↗
paper nausea free (67.1% vs 58.7%, P = .0210) PMID 21457235 ↗
Publications
- Tepper SJ, Kori SH, Borland SW, Wang MH, Hu B, Mathew NT, Silberstein SD. Efficacy and safety of MAP0004, orally inhaled DHE in treating migraines with and without allodynia. Headache. 2012 Jan;52(1):37-47. doi: 10.1111/j.1526-4610.2011.02041.x. Epub 2011 Nov 22.
- Tepper SJ, Kori SH, Goadsby PJ, Winner PK, Wang MH, Silberstein SD, Cutrer FM. MAP0004, orally inhaled dihydroergotamine for acute treatment of migraine: efficacy of early and late treatments. Mayo Clin Proc. 2011 Oct;86(10):948-55. doi: 10.4065/mcp.2011.0093.
- Aurora SK, Silberstein SD, Kori SH, Tepper SJ, Borland SW, Wang M, Dodick DW. MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine. Headache. 2011 Apr;51(4):507-17. doi: 10.1111/j.1526-4610.2011.01869.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dihydroergotamine | Small molecule | 1 mg | Inhaled |