Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine

November 27, 2024 updated by: Neurolief Ltd.

The SP-303 PERL Study - Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine

The PERL Study will evaluate the safety and efficacy of a self-administered preventive treatment for migraine headache using combined occipital and trigeminal nerve stimulation (Relivion®).

This is a prospective, non-randomized, single arm, multi-center study designed to evaluate the use of Relivion® in reducing the frequency of headache days against a sham performance goal.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will include the following study visits & phases:

  • Visit 1 Screening
  • Run-in (Baseline) Period - Daily migraine headache diary.
  • Visit 2 Enrollment -Study enrollment, device and regimen training.
  • Treatment Period- Relivion® migraine preventive treatment for 12 consecutive weeks. Patients will be required to fill in a daily migraine diary.
  • Visit 3 Follow Up Visit.
  • Visit 4 Follow Up Visit.
  • Visit 5 End of study.

After completion of visit 5 the subject's participation will be over.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects 18 years of age and older.
  2. Subject meets the ICHD-3 (2018) diagnostic criteria for either Episodic migraine (<15 headache (HA) days/month) or Chronic (at least 15 days of HA/month with at least 8 days/month migraine days (migraine with and without aura) for > 3 months).
  3. Subject migraine age of onset <50 years of age.
  4. History of 6 to 24 headache days on average per month for the 3 months preceding study enrolment (based on participant report).
  5. Completed at least 21 out of 28 days in the eDiary during run-in period. Partially completed data for the run-in period will be adjusted to reflect an estimated number of days with the outcome of interest per 28-day interval by using the formula (28/x)*y, where x is the number of days with observed data per 28-day period and y is the number of observed days with the outcome of interest.
  6. Subject reports 6-24 headache days per 28 days, confirmed by 28 days or adjusted 28 days baseline diary.
  7. Subjects 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 3 months prior to the screening visit, and the dose is not expected to change during the course of the study.
  8. Subject is willing to and capable of complying with the specified study requirements, provided written Informed Consent can complete the electronic diaries, and can be contacted by telephone.

Exclusion Criteria:

  1. Initiating or changing the type, dosage, or frequency of any medications for other indications than migraine that are determined to potentially interfere with the study.
  2. Failure on ≥2 well-conducted preventive treatments. A treatment failure (lack of efficacy) trial is characterized as a Level A or Level B evidence-based preventive treatment (medications or a MAB or preventive gepant) for migraine preventive trial taken for a minimum of 2 months, at a minimally adequate dose, that produced less than 50% improvement in MMD reduction). Failure to tolerate a preventive treatment does not constitute a preventive treatment failure.
  3. History of other chronic headache conditions such as Chronic tension-type headache, Medication Overuse Headache, New Daily Persistent Headache, and Cluster Headache in the prior 6 months.
  4. Use of opiates or barbiturates medications in the prior 3 months.
  5. Received parenteral infusions for migraine within the previous 2 weeks.
  6. Subject has known uncontrolled epilepsy.
  7. History of neuro-interventional procedures such as nerve blocks (within the last month), Botulinum Toxin (within the last 3-months), neurosurgical interventions in the head or neck, or implanted/wearable neurostimulators, electronic devices in the head, cardiac pacemaker, surgical clips above the shoulder line or medical pumps, except for dental implants.
  8. Current drug abuse or alcoholism.
  9. Subjects participating in other clinical trials evaluating experimental treatments or procedures.
  10. Skin lesion, scars, or inflammation in the region of the stimulating electrodes.
  11. Personality or somatoform disorder.
  12. Pregnancy or Lactation.
  13. Women of reproductive age not using a reliable contraceptive method, as determined by the Investigator (NOTE: Females of childbearing potential must have a negative pregnancy test).
  14. Documented history of cerebrovascular event.
  15. Subject with a recent history of traumatic brain injury (TBI), defined as a disruption in the normal function of the brain that can be caused by a bump, blow, or jolt to the head, or penetrating head injury, within 3 months of study enrollment.
  16. Subjects who demonstrate or have a history of any cognitive disorder or impairment, memory loss, dementia, confusion or delirium that, in the opinion of the Investigator, may compromise the integrity of the study data or impact the ability of the subject to comply with the study requirements.
  17. Subject diagnosed with other chronic pain disorder which in the opinion of the Investigator may compromise the integrity of the study data or impact the ability of the subject to comply with the study requirements.
  18. The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
  19. Subject with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active stimulation
Relivion® device- Active stimulation
Device: Relivion®
Active stimulation device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean change in Monthly Migraine Days (MMD).
Time Frame: 3 months
Mean change from baseline (M0) in Monthly Migraine Days (MMD) comparing with the last 28 treatment days (M3: weeks 9-12).
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of responder subjects
Time Frame: 3 months
Proportion of responder subjects defined as the percent of subjects achieving at least 50% reduction from baseline (M0) in their monthly migraine days comparing with the last 28 treatment days (M3: weeks 9-12).
3 months
Mean change in monthly acute anti-migraine headache drug days.
Time Frame: 3 months
Mean change in baseline (M0) monthly acute anti-migraine headache drug days comparing with the last 28 treatment days (M3: weeks 9-12).
3 months
Mean change total headache days.
Time Frame: 3 months
Mean change in baseline (M0) total headache days comparing with the last 28 treatment days (M3: weeks 9-12)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neurolief Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stewart J Tepper, MD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP-303-PERL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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