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Migraine Treatment With Nerivio Migra Neurostimulation Device

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ClinicalTrials.gov Identifier: NCT03076515
Recruitment Status : Terminated (Study was prematurely stop based on DMC recommendation)
First Posted : March 10, 2017
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Theranica

Tracking Information
First Submitted Date  ICMJE March 7, 2017
First Posted Date  ICMJE March 10, 2017
Last Update Posted Date May 9, 2018
Actual Study Start Date  ICMJE April 2, 2017
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
pain relief [ Time Frame: 2 hours post treatment ]
Percentage of patients reporting freedom from pain (pain grade 0) 2 hours post treatment without rescue medications in at least 50% of treated attacks
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03076515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Migraine Treatment With Nerivio Migra Neurostimulation Device
Official Title  ICMJE A Prospective, Randomized, Double-blind, Sham Controlled Multi-center Clinical Trial, Migraine Headache Treatment With Nerivio Migra Neurostimulation Device
Brief Summary This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Migraine
Intervention  ICMJE
  • Device: Nerivio Migra neurostimulation
    transcutaneous electrical stimulation
  • Device: Sham Nerivio Migra
    electrical stimulation- shame mode
Study Arms  ICMJE
  • Active Comparator: Nerivio Migra active
    Intervention: Device: Nerivio Migra neurostimulation
  • Sham Comparator: Nerivio Migra placebo
    Intervention: Device: Sham Nerivio Migra
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 19, 2017)
120
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2017)
160
Actual Study Completion Date  ICMJE April 1, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient is 18-75 years old.
  2. Patient meeting the ICHD-3 diagnostic criteria for migraine with and without aura.
  3. Patients reporting 2-8 migraine attacks per month.
  4. Patient must be able and willing to comply with the protocol.
  5. Patient must be able and willing to provide written informed consent.
  6. Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test) and must be willing to use adequate contraceptive means during the study

Exclusion Criteria:

  1. Has other significant pain problem that in the opinion of the investigator may confound the study assessments
  2. Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
  3. Known uncontrolled epilepsy.
  4. Use of Cannabis including medical use.
  5. Has chronic migraine (more than 15 headache days per month).
  6. Changed usage or dosage of migraine preventive medications in the last two months
  7. Has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
  8. Is participating in any other clinical study. -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03076515
Other Study ID Numbers  ICMJE TCH_002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Theranica
Study Sponsor  ICMJE Theranica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian M Grosberg, MD Hartford Healthcare Headache Center
PRS Account Theranica
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP