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NCT01328002 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
A Phase 2 study, sponsored by Forest Laboratories.
- Terminated
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT01328002: Clinical Trial Phase 2 study, sponsored by Forest Laboratories.
NCT01328002 is a Phase 2 study that was terminated before completion, run by Forest Laboratories. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01328002, a Phase 2 study, was terminated before completion, sponsored by Forest Laboratories.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
Primary Outcome
During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline
Interventions
- DRUG Placebo
- DRUG Milnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2011-04-30 |
| Est. Completion | 2012-08-31 |
| Phase | Phase 2 |
Why NCT01328002 stopped before completion
NCT01328002 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01328002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01328002 about?
NCT01328002 is a clinical study titled "Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia". The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
What is the current status of trial NCT01328002?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2011-04-30. Estimated completion is 2012-08-31.
What interventions are being tested in trial NCT01328002?
The interventions under investigation include: Placebo (DRUG), Milnacipran (DRUG).
Who is sponsoring clinical trial NCT01328002?
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 NCT01328002's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 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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