FibromyalgiaPERRFECT-301NCT02211508
Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 301
A study testing RINCE in people with Fibromyalgia, run by Cerephex Corporation at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- RINCE
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 16 sitesUnited States
- Study dates
- Jul 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is male or female, 22 to 65 years of age, inclusive.
- Patient has a diagnosis of primary fibromyalgia as defined by the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia.
- If female, is either not of childbearing potential or is willing to utilize specified practices throughout the study to prevent becoming pregnant.
- Patient is willing and able to refrain or withdraw from the following therapies for the duration of the study: duloxetine, milnacipran, pregabalin, gabapentin, naltrexone, sodium oxybate, and opiates.
- Qualified patients with mild or moderate depression must be clinically stable, without risk of suicidal ideation or behavior, and the dose of allowed anti-depressants should have been stable for at least three months prior to the Baseline clinic visit.
- Patient is willing and able to comply with all protocol-specified requirements.
- Patient is capable of reading and understanding English and has provided written informed consent to participate.
Who cannot join
- The patient suffers from one or more of clinically significant psychiatric condition that could interfere with the patient's well-being or ability to comply with the protocol.
- Patient has a Beck Depression Inventory-II total score greater than 25 at either the Screening visit or Baseline clinic visit.
- The patient is at increased risk of suicide.
- Patient is unable, unwilling or not advised to refrain from or discontinue prohibited medications or treatments.
- Patient has a diagnosis of, or is being treated for, systemic lupus erythematosus, inflammatory arthritis, or other documented systemic autoimmune disorder, Parkinson's disease, multiple sclerosis, or cancer (other than basal or squamous cell skin cancer).
- Patient has any other chronic pain condition that, in the Investigator's or Sponsor's opinion, could interfere with the patient's assessment of his/her fibromyalgia status.
Show all 18Show fewer
- Patient has a history of severe, refractory or uncontrolled migraine headaches, seizure disorder or clinically significant cognitive dysfunction.
- Patient is pregnant or planning to become pregnant within the next 6 months.
- Patient has a body mass index greater than 40 at the Screening visit.
- Patient has a history of cranial electrical stimulation or transcutaneous magnetic stimulation within 2 years of screening, or electroconvulsive therapy within 5 years of screening.
- Patient has a metal implant at or above the level of the 7th cervical vertebra, a cardiac pacemaker or defibrillator, or vagus nerve stimulator.
- Any recent surgery or anticipated need for surgery that might confound results or interfere with patient's ability to comply with the protocol.
- Myocardial infarction during the 12 months prior to screening, uncontrolled hypertension, active cardiac disease, clinically significant cardiac rhythm or conduction abnormality, or anticipation of bypass or other cardiac surgery within the next 12 months.
- Current systemic infection (e.g., HIV, hepatitis B or C; Lyme disease).
- Patient is using opiates on a regular or frequent basis.
- Pending or current litigation or disability claim (including Workman's Compensation).
- History of significant alcohol and/or drug abuse or dependency within preceding 5 years, or a positive result on the screening (or subsequent) drug screen indicating use of an illicit substance.
- Patient has participated in an investigational study of a therapeutic treatment within 90 days prior to Screening visit or is currently participating in another clinical trial.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216
Chicago Research Center
Chicago, Illinois, 60634
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45219
Avail Clinical Research
DeLand, Florida, 32720
Sunstone Medical Research
Medford, Oregon, 97504
Neurovations
Napa, California, 94558
Fieve Clinical Research
New York, New York, 10168
Compass Research LLC
Orlando, Florida, 32806
Premier Research
Phoenix, Arizona, 85027
Superior Research LLC
Sacramento, California, 95825
Fatigue Consultation Clinic
Salt Lake City, Utah, 84102
Artemis Institute for Clinical Research
San Diego, California, 92103
Swedish Clinical Research
Seattle, Washington, 98122
Omega Medical Research
Warwick, Rhode Island, 02886
Upstate Clinical Research Associates
Williamsville, New York, 14221
About this study
Official title: A Double-Blinded, Randomized, Sham-Controlled, Pivotal Study of the NeuroPoint Device for the Treatment of Pain Associated With Fibromyalgia
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 200 fibromyalgia patients will be randomized into one of two study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all, while the other group will receive active RINCE treatment. The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' weekly worst pain scores. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.
- Conditions
- Fibromyalgia
- Being tested
- RINCE
- Keywords
- fibromyalgia, pain, stimulation
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RINCEDevice
Also called RINCE therapy, RINCE therapy delivered by the NeuroPoint device
The NeuroPoint device is used to deliver repeat applications of RINCE therapy
| Study group | Role | What they receive |
|---|---|---|
| 12-week RINCE | Active comparator | RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device Receives: Device: RINCE |
| Sham RINCE | Sham comparator | Sham RINCE - sham RINCE therapy involving 24 total sham applications from NeuroPoint device Receives: Device: RINCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in patients' 24-hour recall worst pain intensity
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 worst pain intensity using an 11-point (0-10) numerical rating scale.
Measured: Assessed at 12 weeks
Secondary outcomes (3)
Patient self-reported Global Impression of Change
Measured: Assessed at 12 weeks
Proportion of patients in the treatment and sham groups whose average daily worst pain intensity decreased by at least 50%
Worst pain intensity evaluated using an 11-point (0-10) numerical rating scale.
Measured: Assessed at 12 weeks
Change from baseline in Revised Fibromyalgia Impact Questionnaire
Measured: Assessed at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Trial terminated Feb '15. Interim analysis results missed primary endpoint, intended signal not delivered in Tx arm, sham results as expected. No safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerephex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R. Michael Gendreau, MD PhD, Study director, Cerephex Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211508
- Sponsor's protocol ID
- NPT-301
- Acronym
- PERRFECT-301
- Status last verified
- Aug 2016
- First submitted
- 6 Aug 2014
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hargrove JB, Bennett RM, Simons DG, Smith SJ, Nagpal S, Deering DE. A randomized placebo-controlled study of noninvasive cortical electrostimulation in the treatment of fibromyalgia patients. Pain Med. 2012 Jan;13(1):115-24. doi: 10.1111/j.1526-4637.2011.01292.x.
PubMed 22233397Hargrove JB, Bennett RM, Clauw DJ. Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. Arch Phys Med Rehabil. 2012 Oct;93(10):1868-71. doi: 10.1016/j.apmr.2012.04.006. Epub 2012 Apr 21.
PubMed 22525670
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized, Sham-Controlled, Pivotal Study of the NeuroPoint Device for the Treatment of Pain Associated With Fibromyalgia
- ClinicalTrials.gov ID
- NCT02211508
- Acronym / sponsor ID
- PERRFECT-301 / NPT-301
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, pain, stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated Feb '15. Interim analysis results missed primary endpoint, intended signal not delivered in Tx arm, sham results as expected. No safety issues.
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Cerephex CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 200 fibromyalgia patients will be randomized into one of two study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all, while the other group will receive active RINCE treatment. The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' weekly worst pain scores. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-week RINCE | Active comparator | Device: RINCERINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device |
| Sham RINCE | Sham comparator | Device: RINCESham RINCE - sham RINCE therapy involving 24 total sham applications from NeuroPoint device |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is male or female, 22 to 65 years of age, inclusive.
- Patient has a diagnosis of primary fibromyalgia as defined by the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia.
- If female, is either not of childbearing potential or is willing to utilize specified practices throughout the study to prevent becoming pregnant.
- Patient is willing and able to refrain or withdraw from the following therapies for the duration of the study: duloxetine, milnacipran, pregabalin, gabapentin, naltrexone, sodium oxybate, and opiates.
- Qualified patients with mild or moderate depression must be clinically stable, without risk of suicidal ideation or behavior, and the dose of allowed anti-depressants should have been stable for at least three months prior to the Baseline clinic visit.
Key exclusion criteria (18 listed)
- The patient suffers from one or more of clinically significant psychiatric condition that could interfere with the patient's well-being or ability to comply with the protocol.
- Patient has a Beck Depression Inventory-II total score greater than 25 at either the Screening visit or Baseline clinic visit.
- The patient is at increased risk of suicide.
- Patient is unable, unwilling or not advised to refrain from or discontinue prohibited medications or treatments.
- Patient has a diagnosis of, or is being treated for, systemic lupus erythematosus, inflammatory arthritis, or other documented systemic autoimmune disorder, Parkinson's disease, multiple sclerosis, or cancer (other than basal or squamous cell skin cancer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RINCEAlso: RINCE therapy, RINCE therapy delivered by the NeuroPoint deviceThe NeuroPoint device is used to deliver repeat applications of RINCE therapy | Device | 12-week RINCE, Sham RINCE |
Primary outcome
Change from baseline in patients' 24-hour recall worst pain intensity
Time frame: Assessed at 12 weeks
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 worst pain intensity using an 11-point (0-10) numerical rating scale.
3 secondary outcomes
Patient self-reported Global Impression of Change
Time frame: Assessed at 12 weeks
Proportion of patients in the treatment and sham groups whose average daily worst pain intensity decreased by at least 50%
Time frame: Assessed at 12 weeks
Change from baseline in Revised Fibromyalgia Impact Questionnaire
Time frame: Assessed at 12 weeks
Results and safety
The study was stopped early (reason given: Trial terminated Feb '15. Interim analysis results missed primary endpoint, intended signal not delivered in Tx arm, sham results as expected. No safety issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Background: PubMed 22233397Hargrove JB, Bennett RM, Simons DG, Smith SJ, Nagpal S, Deering DE. A randomized placebo-controlled study of noninvasive cortical electrostimulation in the treatment of fibromyalgia patients. Pain Med. 2012 Jan;13(1):115-24. doi: 10.1111/j.1526-4637.2011.01292.x.
- Background: PubMed 22525670Hargrove JB, Bennett RM, Clauw DJ. Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. Arch Phys Med Rehabil. 2012 Oct;93(10):1868-71. doi: 10.1016/j.apmr.2012.04.006. Epub 2012 Apr 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Michael Gendreau, MD PhD study director
Cerephex Corporation
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RINCE in people with Fibromyalgia, run by Cerephex Corporation at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Trial terminated Feb '15. Interim analysis results missed primary endpoint, intended signal not delivered in Tx arm, sham results as expected. No safety issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in patients' 24-hour recall worst pain intensity (time frame: Assessed at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02211508, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.