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NCT02613949 · ClinicalTrials.gov registry record · NA
Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 202
A NA study, sponsored by Cerephex Corporation.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT02613949: Completed NA study, sponsored by Cerephex Corporation.
NCT02613949 is a NA study that has completed, run by Cerephex Corporation. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02613949, a NA study, has completed, sponsored by Cerephex Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the treatment of pain associated with fibromyalgia. Patients who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 45 fibromyalgia patients will be randomized into one of three study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all. A second group will receive active RINCE treatment at a nominal signal amplitude level (treatment mode 1). A third group will receive active RINCE treatment at a higher than nominal signal amplitude level (treatment mode 2). The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' 24-hour recall average pain scores. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.
Primary Outcome
The primary efficacy endpoint will be the contrast at 12 weeks versus Baseline in the (paired) mean weekly change in patients' self-reported daily (24-hour) recall average pain intensity using an 11-point (0-10) numerical rating scale.
Interventions
- DEVICE RINCE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-07-29 |
| Phase | NA |
What the finished NCT02613949 record still lists
NCT02613949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which RINCE is the first listed.
NCT02613949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02613949 about?
NCT02613949 is a clinical study titled "Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 202". The purpose of this study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the treatment of pain associated with fibromyalgia. Patients who meet the 2010 American College of Rheumat...
What is the current status of trial NCT02613949?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2015-11. Estimated completion is 2016-07-29.
What interventions are being tested in trial NCT02613949?
The interventions under investigation include: RINCE (DEVICE).
Who is sponsoring clinical trial NCT02613949?
This trial is sponsored by Cerephex Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02613949's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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