Phase 3
Completed N=902
Phase 3 Study of MAP0004 in Adult Migraineurs
Migraine Disorders
Source: ClinicalTrials.gov NCT00623636 ↗
Enrolled (actual)
902
Serious AEs
1.0%
Results posted
Oct 2013
Primary outcomePrimary: Number of Subjects With Pain Relief at 2 Hours From Time of First Dose — 136; 231 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Pain Relief at 2 Hours From Time of First Dose |
136; 231 | — |
| PRIMARY Number of Subjects Photophobia Free at 2 Hours From Time of First Dose |
107; 182 | — |
| PRIMARY Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose |
133; 208 | — |
| PRIMARY Number of Subjects Nausea Free at 2 Hours From Time of First Dose |
234; 266 | — |
| SECONDARY Number of Subjects With Sustained Pain Relief From 2 to 24 Hours |
76; 166 | — |
| SECONDARY Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours |
156; 244 | — |
| SECONDARY Number of Subjects With Pain Relief at 4 Hours |
145; 254 | — |
| SECONDARY Number of Subjects With Pain Relief at 10 Minutes |
30; 37 | — |
Eligibility Criteria
Major Inclusion Criteria:
- Male or female between 18 and 65 years of age.
- History of episodic, acute migraine (with or without aura) with onset prior to 50
Major Exclusion Criteria:
- Known allergy or sensitivity or contraindication to study drugs or their formulations
- History of chronic pulmonary disease, coronary artery disease (CAD), liver disease, kidney disease, seizures, stroke, or major psychiatric condition.
- Any condition that, in the opinion of the Investigator, would make the subject unsuitable for study participation
Data sourced from ClinicalTrials.gov (NCT00623636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.