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NCT01331109 · ClinicalTrials.gov registry record · Phase 2
Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia
A Phase 2 study, sponsored by Forest Laboratories.
- Terminated
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT01331109: Clinical Trial Phase 2 study, sponsored by Forest Laboratories.
NCT01331109 is a Phase 2 study that was terminated before completion, run by Forest Laboratories. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01331109, a Phase 2 study, was terminated before completion, sponsored by Forest Laboratories.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
Primary Outcome
Number of Patients who experience one or more treatment emergent adverse event (TEAE)
Interventions
- DRUG Milnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
Why NCT01331109 stopped before completion
NCT01331109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Milnacipran is the first listed.
NCT01331109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01331109 about?
NCT01331109 is a clinical study titled "Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia". The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
What is the current status of trial NCT01331109?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2011-04. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01331109?
The interventions under investigation include: Milnacipran (DRUG).
Who is sponsoring clinical trial NCT01331109?
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 NCT01331109's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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