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Trial record 1 of 1 for:    TCH008
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Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04828707
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : March 28, 2022
Sponsor:
Information provided by (Responsible Party):
Theranica

Brief Summary:

Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. This study intends to demonstrate the safety and efficacy of the Nwrivio for migraine prevention.

The study is a prospective, randomized, double-blind, sham-controlled, multicenter study, conducted in three phases.

The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase, an 8-week double-blind preventive treatment phase, and a 4-week open-label phase.

Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow-up pre-emptive phase.

The primary endpoint is the mean change in the average of migraine headache days per month comparing the 4-week baseline phase (weeks 1 through 4) with the last 28 days of the treatment phase (weeks 9 through 12).


Condition or disease Intervention/treatment Phase
Migraine Device: Nerivio active device Device: Nerivio sham device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, sham-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Double-blind, Sham-controlled Multi-center Clinical Study Assessing the Safety and Efficacy of Nerivio for the Preventive Treatment of Migraine
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Active Comparator: Migraine prevention treatment with active Nerivio
Participants will treat with an active Nerivio device every other day for migraine prevention.
Device: Nerivio active device
Nerivio neurostimulator of conditional pain modulation (CPM)

Sham Comparator: Migraine prevention treatment with sham Nerivio
Participants will treat with a sham (placebo) Nerivio device every other day for migraine prevention.
Device: Nerivio sham device
Nerivio neurostimulator with an electrical output not intended for neurostimulation




Primary Outcome Measures :
  1. Reduction in migraine days [ Time Frame: 3 months ]

    Mean change in number of migraine headache days per month comparing the 4-week baseline phase (weeks 1 through 4) with the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12).

    A migraine headache day is defined as a calendar day with headache that is accompanied by at least one of the following symptoms: aura, photophobia, phonophobia, nausea and/or vomiting; or a calendar day with a headache that is treated with a migraine-specific acute medication.


  2. Rate of Adverse events (Safety and Tolerability) [ Time Frame: 3 months ]
    The incidence of adverse events in general by seriousness, severity and association to the device.


Secondary Outcome Measures :
  1. Reduction in moderate/severe headache days [ Time Frame: 3 months ]

    Mean change in number of moderate/severe headache days per month comparing the 4-week baseline phase (weeks 1 through 4) with the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12).

    A moderate/severe headache day is defined as a calendar day with a moderate or severe headache.


  2. Reduction headache days [ Time Frame: 3 months ]
    Mean change in the number of headache days per month from the 4-week baseline phase (weeks 1 through 4) to the last 4 weeks of the treatment phase (weeks 9 through 12). A headache day is defined as a calendar day with headache (at any severity).

  3. Reduction of 50% in headache days [ Time Frame: 3 months ]
    Percentage of patients achieving at least 50% reduction from baseline in the mean number of headache days (all severities) per month in the last 4 weeks of the treatment phase (weeks 9 through 12).

  4. Reduction in HIT score [ Time Frame: 3 months ]
    Mean change in the HIT-6 total score from baseline to the last 4 weeks of the treatment phase (weeks 9 through 12).

  5. Reduction in MSQ score [ Time Frame: 3 months ]
    Mean change in the MSQ role function from baseline the last 4 weeks of the treatment phase (weeks 9 through 12).


Other Outcome Measures:
  1. Reduction in migraine medication intake [ Time Frame: 3 months ]
    Reduction in the mean number of acute headache/migraine medication days per month in the last 4 weeks of the treatment phase (weeks 9 through 12) compared to Baseline (weeks 1 through 4).

  2. Percentage of freedom from headache post 2 hours following prodrome treatment [ Time Frame: 2 hours post treatment at follow up phase ]
    Percentage of participants who treat for the first treatment in the pre-emptive phase, during the prodrome, when they are pain-free, and remain pain-free during the following 2 hours after the treatment, without use of acute medication.

  3. Percentage of freedom from headache post 24 hours following prodrome treatment [ Time Frame: 24 hours post treatment at follow up phase ]
    Percentage of participants who treat for the first treatment in the pre-emptive phase, during the prodrome, when they are pain-free, and remain pain-free during the following 24 hours after the treatment, without use of acute medication.

  4. Percentage of reduction of headache post 24 hours from prodrome treatment [ Time Frame: 24 hours post treatment at follow up phase ]
    Percentage of patients who treat during the prodrome, when they are pain free, and remain either pain free or with mild pain during the following 24 hours after the treatment without use of acute medication.

  5. Feasibility of migraine prediction algorithm [ Time Frame: 3 months ]
    Analysis of the daily information provided by the participants for the purpose of predicting their migraine days

  6. Health economic analysis [ Time Frame: 12 weeks ]

    Health economics analysis of the difference between subjects using Nerivio as a therapy and those who do not with respect to:

    1. Absenteeism - number of missed work/school days
    2. Presenteeism - number of work/school days with moderate/severe functional disability
    3. Healthcare provider appointments
    4. ED visits
    5. Brain MRI/CT scans



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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75 years old.
  2. Must have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic (at least 15 days of HA/ month with migraine days (migraine with and without aura) at least 8 days/ month for > 3 months) or non-chronic migraine.
  3. History of 6 to 24 headache days per 28-day period for each of the 3 months preceding study enrolment (based on participant report).
  4. Subject on prophylactic migraine treatment are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 2 months prior to the screening visit, and the dose is not expected to change during the course of the study.
  5. Have personal access to a smartphone (24/7).
  6. Must be able and willing to comply with the protocol.
  7. Must be able and willing to provide informed consent..

Exclusion Criteria:

  1. An active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
  2. Uncontrolled epilepsy.
  3. History of use of opioids or barbiturates on more than 4 days a month in the last 6 months.
  4. Current participation in any other interventional clinical study
  5. Subject without basic cognitive and motor skills required for operating a smartphone.
  6. Pregnant or breastfeeding.
  7. Other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
  8. Prior experience with the Nerivio device.

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): NCT04828707


Contacts
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Contact: Dagan Harris, PhD +97272 3909755 daganh@theranica.com
Contact: Maya Vizel +97272 3909755 mayav@theranica.com

Locations
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Sponsors and Collaborators
Theranica
Investigators
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Study Chair: Robert Cowan, MD Stanford Health Care
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Responsible Party: Theranica
ClinicalTrials.gov Identifier: NCT04828707    
Other Study ID Numbers: TCH008
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: March 28, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases