Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 301

Fibromyalgia Clinical Trial

— PERRFECT-301  

Official title:

A Double-Blinded, Randomized, Sham-Controlled, Pivotal Study of the NeuroPoint Device for the Treatment of Pain Associated With Fibromyalgia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02211508
• Other study ID #: NPT-301
• Status: Terminated
• Phase: N/A
• First received: August 6, 2014
• Last updated: August 5, 2016
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2016
• Source: Cerephex Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 236
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• RINCE
The NeuroPoint device is used to deliver repeat applications of RINCE therapy

Locations

Country	Name	City	State
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Chicago Research Center	Chicago	Illinois
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Avail Clinical Research	Deland	Florida
United States	Sunstone Medical Research	Medford	Oregon
United States	Neurovations	Napa	California
United States	Fieve Clinical Research	New York	New York
United States	Compass Research LLC	Orlando	Florida
United States	Premier Research	Phoenix	Arizona
United States	Superior Research LLC	Sacramento	California
United States	Fatigue Consultation Clinic	Salt Lake City	Utah
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Swedish Clinical Research	Seattle	Washington
United States	Omega Medical Research	Warwick	Rhode Island
United States	Upstate Clinical Research Associates	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cerephex Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hargrove 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed at 12 weeks	No
Secondary	Patient self-reported Global Impression of Change		Assessed at 12 weeks	No
Secondary	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.	Assessed at 12 weeks	No
Secondary	Change from baseline in Revised Fibromyalgia Impact Questionnaire		Assessed at 12 weeks	No

External Links

•   NeuroPoint / RINCE Clinical Study Website