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A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
This study has been completed.
Sponsor:
SK Life Science
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT00109083
First received: April 22, 2005
Last updated: August 1, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment in reducing the number of migraine headaches when added to a person's usual medications for acute migraine headache relief.
| Condition | Intervention | Phase |
|---|---|---|
| Migraine Headaches | Drug: RWJ-333369 | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine |
Resource links provided by NLM:
Further study details as provided by SK Life Science:
Primary Outcome Measures:
- Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2002 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Established history of migraines for at least 1 year;
- Have between 3 and 12 migraine attacks per month, and no more than 15 headache days in total per month;
- Migraines must have first started before age 50.
Exclusion Criteria:
- Most frequent headache type is not migraine;
- Failed 3 or more studies of effective migraine-preventing medications;
- Overuse of pain medications to treat migraines;
- Not willing to stop use of migraine-preventing medications;
- Significant serious concomitant diseases.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109083
Show 25 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109083
Show 25 Study Locations
Sponsors and Collaborators
SK Life Science
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical R & D, L.L.C., Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | SK Life Science |
| ClinicalTrials.gov Identifier: | NCT00109083 History of Changes |
| Other Study ID Numbers: |
333369-MIG-2001 |
| Study First Received: | April 22, 2005 |
| Last Updated: | August 1, 2012 |
Keywords provided by SK Life Science:
|
Migraine Headaches Migraine headaches Head pain |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on July 18, 2017