Phase 2
N=676
MK3207 for Treatment of Acute Migraines (3207-005)
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00712725 ↗Enrolled (actual)
676
Serious AEs
0.4%
Results posted
Nov 2010
Primary outcome: Primary: Pain Freedom (PF) — 13; 4; 5; 16 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MK3207- 2.5 mg (Drug); MK3207- 5 mg (Drug); MK3207- 10 mg (Drug); MK3207- 20 mg (Drug); MK3207- 50 mg (Drug); MK3207- 100 mg (Drug); Comparator: placebo (unspecified) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Freedom (PF) |
13; 4; 5; 16; 12; 14 | <0.001 sig |
| SECONDARY Pain Relief (PR) |
48; 15; 19; 36; 36; 41 | <0.001 sig |
| SECONDARY Absence of Photophobia |
51; 10; 15; 32; 27; 32 | <0.001 sig |
| SECONDARY Absence of Phonophobia |
57; 12; 18; 35; 35; 38 | <0.001 sig |
| SECONDARY Absence of Nausea |
79; 19; 25; 44; 42; 44 | 0.007 sig |
| SECONDARY Sustained Pain Freedom (SPF) |
10; 4; 2; 13; 10; 12 | <0.001 sig |
Summary
The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of MK3207 in the treatment of acute migraine.
Eligibility Criteria
Inclusion Criteria
- Men and Women from 18 to 65 years of age
- 1+ year history of migraine that typically last from 4 to 72 hours if untreated
- Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months
- Not pregnant or planning to become pregnant in next 6 months
Exclusion Criteria
- Pregnant or breast-feeding, or planning to become pregnant in next 6 months
- Cannot distinguish migraine attacks from tension type headaches
- Migraines are mild or resolve without medication in less than 2 hours
- More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months
- Basilar type or hemiplegic migraine headaches
- More than 50 years old when migraines began
- History of cardiovascular disorder within last 6 months
Data sourced from ClinicalTrials.gov (NCT00712725). 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.