MigraineNCT05804396
Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine
A study testing Relivion® in people with Migraine, run by Neurolief Ltd..
Trial summary
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®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Relivion®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2024to 24 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 years of age and older.
- 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).
- Subject migraine age of onset <50 years of age.
- History of 6 to 24 headache days on average per month for the 3 months preceding study enrolment (based on participant report).
- 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.
- Subject reports 6-24 headache days per 28 days, confirmed by 28 days or adjusted 28 days baseline diary.
- 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.
- 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.
Who cannot join
- 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.
- 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.
- 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.
- Use of opiates or barbiturates medications in the prior 3 months.
- Received parenteral infusions for migraine within the previous 2 weeks.
- Subject has known uncontrolled epilepsy.
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- 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.
- Current drug abuse or alcoholism.
- Subjects participating in other clinical trials evaluating experimental treatments or procedures.
- Skin lesion, scars, or inflammation in the region of the stimulating electrodes.
- Personality or somatoform disorder.
- Pregnancy or Lactation.
- 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).
- Documented history of cerebrovascular event.
- 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.
- 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.
- 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.
- The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
- Subject with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters.
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Relivion®
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relivion®Device
Active stimulation device
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Relivion® device- Active stimulation Receives: Device: Relivion® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Monthly Migraine Days (MMD).
Mean change from baseline (M0) in Monthly Migraine Days (MMD) comparing with the last 28 treatment days (M3: weeks 9-12).
Measured: 3 months
Secondary outcomes (3)
Proportion of responder subjects
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).
Measured: 3 months
Mean change in monthly acute anti-migraine headache drug days.
Mean change in baseline (M0) monthly acute anti-migraine headache drug days comparing with the last 28 treatment days (M3: weeks 9-12).
Measured: 3 months
Mean change total headache days.
Mean change in baseline (M0) total headache days comparing with the last 28 treatment days (M3: weeks 9-12)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start24 Nov 2024
- Primary completion24 Nov 2024
- Study completion24 Nov 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurolief Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stewart J Tepper, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804396
- Sponsor's protocol ID
- SP-303-PERL
- Status last verified
- Nov 2024
- First submitted
- 26 Mar 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SP-303 PERL Study - Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine
- ClinicalTrials.gov ID
- NCT05804396
- Acronym / sponsor ID
- SP-303-PERL
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neurolief Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 24 Nov 2024 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: Relivion®Relivion® device- Active stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects 18 years of age and older.
- 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).
- Subject migraine age of onset <50 years of age.
- History of 6 to 24 headache days on average per month for the 3 months preceding study enrolment (based on participant report).
- 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.
Key exclusion criteria (19 listed)
- 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.
- 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.
- 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.
- Use of opiates or barbiturates medications in the prior 3 months.
- Received parenteral infusions for migraine within the previous 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relivion®Active stimulation device | Device | Active stimulation |
Primary outcome
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 secondary outcomes
Proportion of responder subjects
Time frame: 3 months
Mean change in monthly acute anti-migraine headache drug days.
Time frame: 3 months
Mean change total headache days.
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stewart J Tepper, MD principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Relivion® in people with Migraine, run by Neurolief Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Monthly Migraine Days (MMD). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.