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NCT00366535 · ClinicalTrials.gov registry record · Phase 2
Neurotropin Treatment of Fibromyalgia
A Phase 2 study, sponsored by National Institute of Nursing Research (NINR).
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT00366535: Completed Phase 2 study, sponsored by National Institute of Nursing Research (NINR).
NCT00366535 is a Phase 2 study that has completed, run by National Institute of Nursing Research (NINR). The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00366535, a Phase 2 study, has completed, sponsored by National Institute of Nursing Research (NINR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of the experimental drug, neurotropin, for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects women, fibromyalgia causes widespread aching and stiffness in muscles. Neurotropin has been used in Japan for many years to treat various chronic painful conditions, including fibromyalgia. Women with fibromyalgia who have been treated unsuccessfully with standard therapy may be eligible for this study. Patients must have a history of widespread pain for more than half of the days in each of the three months before they enter the study. Candidates are screened with a medical history, physical examination, blood and urine tests, questionnaires and an electrocardiogram (EKG). Participants take their usual medications for fibromyalgia in addition to either neurotropin or a placebo (look-alike medicine with no active ingredient). At 6 weeks and 12 weeks into the study, they return to the NIH Clinical Center for evaluation of their sensitivity to pain and level of physical capability. After 12 weeks, study subjects "cross-over" their medication; that is, patients who took neurotropin for the first 12 weeks of the study take placebo for the next 12 weeks, and vice-versa. Again, after 6 and 12 weeks, patients return for evaluation. Participants have blood and urine tests six times during the study and complete questionnaires each week about their pain, symptoms, and activities.
Primary Outcome
The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item self-administered measure to assess 3 areas of fibromyalgia (FM): function, overall impact, and symptoms. The total FIQ score was the primary outcome of the study. The total FIQ score is the sum of the 3 areas measured in the FIQ. The maximum possible total FIQ score is 100, with a minimum score of 10. The average FM patient scores about 50, severely afflicted FM patients are usually 70 and above. Data analysis is ongoing from data c
Interventions
- DRUG Placebo
- DRUG Neurotropin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2006-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT00366535 record still lists
NCT00366535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00366535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00366535 about?
NCT00366535 is a clinical study titled "Neurotropin Treatment of Fibromyalgia". This study will examine the safety and effectiveness of the experimental drug, neurotropin, for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects women, fibromyalgia causes widespread aching and stiffness in muscles. Neurotropin has been used in Japan for many...
What is the current status of trial NCT00366535?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2006-08. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00366535?
The interventions under investigation include: Placebo (DRUG), Neurotropin (DRUG).
Who is sponsoring clinical trial NCT00366535?
This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00366535's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 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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