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A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
NCT00109083 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG RWJ-333369
Study Locations (20)
Florida
- — Miami
- — St. Petersburg
Massachusetts
- — Brockton
- — Springfield
Ohio
- — Cincinnati
- — Mogadore
Texas
- — Austin
- — Houston
Alabama
- — Northport
Arizona
- — Phoenix
Arkansas
- — Little Rock
California
- — Berkeley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2002-03 |
| Est. Completion | 2006-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00109083
The ClinicalTrials.gov registry entry for NCT00109083 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SK Life Science, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Migraine Headaches appearing as the primary indexed condition, and to 1 intervention — of which RWJ-333369 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00109083 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, Massachusetts, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00109083 about?
NCT00109083 is a clinical study titled "A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine". 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.
What is the current status of trial NCT00109083?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2002-03. Estimated completion is 2006-02.
What conditions does trial NCT00109083 study?
This clinical trial studies the following conditions: Migraine Headaches. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00109083?
The interventions under investigation include: RWJ-333369 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00109083?
This trial is sponsored by SK Life Science, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00109083 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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