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NCT01125423 · ClinicalTrials.gov registry record · Phase 4
Study of Fibromyalgia Treated With Milnacipran
A Phase 4 study, sponsored by Albany Medical College.
- Completed
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT01125423: Completed Phase 4 study, sponsored by Albany Medical College.
NCT01125423 is a Phase 4 study that has completed, run by Albany Medical College. 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
NCT01125423, a Phase 4 study, has completed, sponsored by Albany Medical College.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. This information will then be used to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (milnacipran) and others do not. The investigators expect to learn more about the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients. The investigators hypotheses are: 1. The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation. 2. Fibromyalgia patients may have different sites of innervation. 3. Milnacipran may have a therapeutic effect on some fibromyalgia patients. 4. Abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran.
Primary Outcome
Patients will be evaluated prior to being started on milnacipran and again after 8 weeks. We will use data from VAS scores, sleep diaries and quantitative sensory testing.
Interventions
- PROCEDURE Skin Biopsy
- DRUG Milnacipran
- PROCEDURE Skin biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-01 |
| Phase | Phase 4 |
What the finished NCT01125423 record still lists
NCT01125423 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 3 interventions - of which Skin Biopsy is the first listed.
NCT01125423 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01125423 about?
NCT01125423 is a clinical study titled "Study of Fibromyalgia Treated With Milnacipran". The purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. This information will then be used to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (milnacipran...
What is the current status of trial NCT01125423?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2010-05. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01125423?
The interventions under investigation include: Skin Biopsy (PROCEDURE), Milnacipran (DRUG), Skin biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT01125423?
This trial is sponsored by Albany Medical College, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01125423'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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