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Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 301 (PERRFECT-301)

This study has been terminated.
(Trial terminated Feb '15. Interim analysis results missed primary endpoint, intended signal not delivered in Tx arm, sham results as expected. No safety issues.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02211508
First Posted: August 7, 2014
Last Update Posted: August 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cerephex Corporation
  Purpose
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.

Condition Intervention
Fibromyalgia Device: RINCE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blinded, Randomized, Sham-Controlled, Pivotal Study of the NeuroPoint Device for the Treatment of Pain Associated With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Cerephex Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]
    Worst pain intensity evaluated using an 11-point (0-10) numerical rating scale.

  • Change from baseline in Revised Fibromyalgia Impact Questionnaire [ Time Frame: Assessed at 12 weeks ]

Enrollment: 236
Study Start Date: July 2014
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 12-week RINCE
RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device
Device: RINCE
The NeuroPoint device is used to deliver repeat applications of RINCE therapy
Other Names:
  • RINCE therapy
  • RINCE therapy delivered by the NeuroPoint device
Sham Comparator: Sham RINCE
Sham RINCE - sham RINCE therapy involving 24 total sham applications from NeuroPoint device
Device: RINCE
The NeuroPoint device is used to deliver repeat applications of RINCE therapy
Other Names:
  • RINCE therapy
  • RINCE therapy delivered by the NeuroPoint device

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211508


Locations
United States, Alabama
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
United States, Arizona
Premier Research
Phoenix, Arizona, United States, 85027
United States, California
Neurovations
Napa, California, United States, 94558
Superior Research LLC
Sacramento, California, United States, 95825
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
United States, Florida
Avail Clinical Research
Deland, Florida, United States, 32720
Compass Research LLC
Orlando, Florida, United States, 32806
United States, Illinois
Chicago Research Center
Chicago, Illinois, United States, 60634
United States, Michigan
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, New York
Fieve Clinical Research
New York, New York, United States, 10168
Upstate Clinical Research Associates
Williamsville, New York, United States, 14221
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45219
United States, Oregon
Sunstone Medical Research
Medford, Oregon, United States, 97504
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, Utah
Fatigue Consultation Clinic
Salt Lake City, Utah, United States, 84102
United States, Washington
Swedish Clinical Research
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Cerephex Corporation
Investigators
Study Director: R. Michael Gendreau, MD PhD Cerephex Corporation
  More Information

Additional Information:
Publications:
Responsible Party: Cerephex Corporation
ClinicalTrials.gov Identifier: NCT02211508     History of Changes
Other Study ID Numbers: NPT-301
First Submitted: August 6, 2014
First Posted: August 7, 2014
Last Update Posted: August 9, 2016
Last Verified: August 2016

Keywords provided by Cerephex Corporation:
fibromyalgia
pain
stimulation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases