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NCT01014585 · ClinicalTrials.gov registry record · Phase 4
Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia
A Phase 4 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 340
- Enrollment target
NCT01014585: Completed Phase 4 study, sponsored by Forest Laboratories.
NCT01014585 is a Phase 4 study that has completed, run by Forest Laboratories. The registered enrollment target is 340 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01014585, a Phase 4 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 340 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.
Primary Outcome
Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a \< 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment
Interventions
- DRUG Placebo
- DRUG Milnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2009-11 |
| Phase | Phase 4 |
What the finished NCT01014585 record still lists
NCT01014585 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01014585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01014585 about?
NCT01014585 is a clinical study titled "Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia". The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms followi...
What is the current status of trial NCT01014585?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 340 participants. The study started on 2009-11.
What interventions are being tested in trial NCT01014585?
The interventions under investigation include: Placebo (DRUG), Milnacipran (DRUG).
Who is sponsoring clinical trial NCT01014585?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01014585's enrollment target sits among peer trials
340 246th of 2000 higher than 1,753 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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