|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00712725 |
|
Date of registration:
|
08/07/2008 |
|
Primary sponsor: |
|
|
Public title:
|
MK3207 for Treatment of Acute Migraines (3207-005)(COMPLETED)
|
|
Scientific title:
|
A Phase IIb, Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-finding Study of MK3207 in the Treatment of Acute Migraine |
|
Date of first enrolment:
|
July 2008 |
|
Target sample size:
|
676 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00712725 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Belgium
|
Canada
|
Germany
|
Italy
|
Sweden
|
United States
| | |
|
Contacts
|
|
Name:
|
Medical Monitor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Merck |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Migraine
|
|
Intervention(s)
|
|
Drug: Comparator: placebo (unspecified)
|
|
Drug: MK3207- 10 mg
|
|
Drug: MK3207- 100 mg
|
|
Drug: MK3207- 2.5 mg
|
|
Drug: MK3207- 20 mg
|
|
Drug: MK3207- 5 mg
|
|
Drug: MK3207- 50 mg
|
|
Primary Outcome(s)
|
|
Pain Freedom (PF)
[Time Frame: 2 hours postdose]
|
|
Secondary Outcome(s)
|
|
Absence of Nausea
[Time Frame: 2 hours postdose]
|
|
Absence of Phonophobia
[Time Frame: 2 hours postdose]
|
|
Absence of Photophobia
[Time Frame: 2 hours postdose]
|
|
Pain Relief (PR)
[Time Frame: 2 hours postdose]
|
|
Sustained Pain Freedom (SPF)
[Time Frame: 2-24 hours postdose]
|
|
Secondary ID(s)
|
|
2008_536
|
|
MK-3207-005
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|