CClinicalTrials.gg
CompletedNCT00109083Updated Aug 2, 2012

A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine

A Phase 2 interventional study of RWJ-333369 in Migraine Headaches, sponsored by SK Life Science, Inc.. Completed at 25 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-08-02.

Sponsored by SK Life Science, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Migraine Headaches

Keywords

  • Migraine
  • Headaches
  • Migraine headaches
  • Head pain
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 300 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

SK Life Science, Inc. is the lead sponsor of 41 studies on the registry; 2 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
300 participants

Interventions

  • DrugRWJ-333369
06

What researchers measure

Primary outcomes

  1. Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.

07

Study locations

25 sites
  • Northport, Alabama, United States
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Berkeley, California, United States
  • Golden, Colorado, United States
  • Miami, Florida, United States
  • St. Petersburg, Florida, United States
  • Chicago, Illinois, United States
  • Baton Rouge, Louisiana, United States
  • Brockton, Massachusetts, United States
  • Springfield, Massachusetts, United States
  • Chaska, Minnesota, United States
  • Springfield, Missouri, United States
  • Greensboro, North Carolina, United States
  • Bismarck, North Dakota, United States
  • Cincinnati, Ohio, United States
  • Mogadore, Ohio, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Houston, Texas, United States
  • Lake Jackson, Texas, United States
  • Richardson, Texas, United States
  • Alexandria, Virginia, United States
  • Olympia, Washington, United States
  • Middleton, Wisconsin, United States
08

References and documents

Publications

  • Cady RK, Mathew N, Diener HC, Hu P, Haas M, Novak GP; Study Group. Evaluation of carisbamate for the treatment of migraine in a randomized, double-blind trial. Headache. 2009 Feb;49(2):216-26. doi: 10.1111/j.1526-4610.2008.01326.x. PubMed 19222595 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00109083
Lead sponsor
SK Life Science, Inc.
Responsible party
Sponsor
First posted
Apr 25, 2005
Start date
Mar 2002
Primary completion
Feb 2006
Completion
Feb 2006
Last update
Aug 2, 2012

Study contacts

Johnson & Johnson Pharmaceutical R & D, L.L.C., Clinical Trial
study director · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion