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NCT00443352 · ClinicalTrials.gov registry record · Phase 4
A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache
A Phase 4 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT00443352: Completed Phase 4 study, sponsored by Thomas Jefferson University.
NCT00443352 is a Phase 4 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 27 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00443352, a Phase 4 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.
Primary Outcome
Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).
Interventions
- DRUG duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2007-08 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
What the finished NCT00443352 record still lists
NCT00443352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which duloxetine is the first listed.
NCT00443352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00443352 about?
NCT00443352 is a clinical study titled "A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache". This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment pe...
What is the current status of trial NCT00443352?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2007-08. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00443352?
The interventions under investigation include: duloxetine (DRUG).
Who is sponsoring clinical trial NCT00443352?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00443352's enrollment target sits among peer trials
27 1651st of 2000 higher than 346 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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