Acute MigraineNCT03631550

The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

A study testing Relivion active in people with Acute Migraine, run by Neurolief Ltd. at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

this study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relivion®) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Migraine
What is being tested?: Relivion active
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 187 participants
Where: 12 sitesin 2 countries
Study dates: 29 Nov 2018to 4 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 (International Classification of Headache Disorders)-3 (2018) diagnostic criteria for Migraine with or without aura.
Subject reports 1-6 Migraine attacks per month; other headaches no more than 6 days per month.
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

Subject having received Botox treatment in the head region in the prior 3 months.
Subject having received supraorbital or occipital nerve blocks in the prior month.
Past 6 months of chronic migraine, New Daily Persistent Headache, and chronic tension-type headache per ICHD-3 (2018) diagnostic criteria.
Current medication overuse headache.
Use of opioid medications in the prior 1 month.
Use of barbiturates in the prior 1 month.

Show all 24Show fewer

Subject has >10 headache days per month
Implanted metal/shrapnel or electrical devices in the head (not including dental implants), a cardiac pacemaker or an implanted or wearable defibrillator.
Received parenteral infusions for migraine within the previous 2 weeks.
Subject has known uncontrolled epilepsy.
History of neurosurgical interventions
Subject with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
Current drug abuse or alcoholism.
Subject is participating in any other clinical study.
Skin lesion or inflammation at the region of the stimulating electrodes.
Personality or somatoform disorder.
Pregnancy or Lactation.
Women with child bearing potential without medically acceptable method of contraception (NOTE: Females of child bearing potential must have a negative pregnancy test).
Documented history of cerebrovascular event.
Subject with recent brain or facial trauma (occurred less than 3 months prior to this study).
Subject participated in a previous study with the Relivion device.
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
Subject with other significant pain problem that in the opinion of the investigator may confound the study assessments.

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

United States6 sites

Hartford HealthCare Headache Center
Hartford, Connecticut, 06107
Clinical Research Consortium, an AMR company
Las Vegas, Nevada, 89119
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Yale School of Medicine
New Haven, Connecticut, 06519
Regeneris Medical
North Attleboro, Massachusetts, 02760
Clinical Research Consortium, an AMR company
Tempe, Arizona, 85283

Other trials in United States

Israel6 sites

Barzilai MC
Ashkelon
Hillel Yaffe Medical Center
Hadera
Sharei Zedek MC
Jerusalem
Macabi healtcenter services
Kfar Saba
Laniado MC
Netanya
Macabi healtcenter services
Raanana

Other trials in Israel

About this study

Read the detailed description

The Relivion® is a non-invasive transcutaneous neuro-stimulator is indicated for the acute treatment of migraine with or without aura in subjects 18 years of age or older. The Relivion® is intended to be a prescription device, self-used at home.

Conditions: Acute Migraine
Being tested: Relivion active, Relivion Sham

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Relivion activeDevice
1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation
Relivion ShamDevice
1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation

Study groups in NCT03631550
Study group	Role	What they receive
Active	Active comparator	Relivion Active device Receives: Device: Relivion active
Sham	Sham comparator	Relivion Sham device Receives: Device: Relivion Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation
the number and percent of subjects reporting reduction of migraine headache pain 2 hours post treatment initiation from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack (if rescue therapy was not used)
Measured: 2 hours from treatment initiation

Secondary outcomes (3)

Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation
The number and percentage of subjects reporting improvement in their Most Bothersome Symptom (MBS) other than a headache, 2 hours post-treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack. MBS may be nausea, photophobia, phonophobia
Measured: 2 hours from treatment initiation
Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation
The number and percentage of subjects reporting reduction of migraine headache pain 1-hour post treatment initiation (if rescue therapy was not used), from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack
Measured: 1 hour from treatment initiation
Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation
The number and percentage of subjects who are pain free at 2 hours post treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack
Measured: 2 hours from treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 20184 Aug 2020

First posted15 Aug 2018
Study start29 Nov 2018
Primary completion4 Aug 2020
Study completion4 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 187 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03631550
Sponsor's protocol ID: SP-302 RIME
Status last verified: Sep 2022
First submitted: 13 Aug 2018
Last updated: 22 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Tepper SJ, Grosberg B, Daniel O, Kuruvilla DE, Vainstein G, Deutsch L, Sharon R. Migraine treatment with external concurrent occipital and trigeminal neurostimulation-A randomized controlled trial. Headache. 2022 Sep;62(8):989-1001. doi: 10.1111/head.14350. Epub 2022 Jun 24.
PubMed 35748757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
ClinicalTrials.gov ID: NCT03631550
Acronym / sponsor ID: SP-302 RIME
Conditions: Acute Migraine
Study type: Interventional
Recruitment status: Completed
Enrolment: 187 participants (actual)
Lead sponsor: Neurolief Ltd.Industry (pharma, biotech, devices)
Study start: 29 Nov 2018 (actual)
Primary completion: 4 Aug 2020 (actual)
Study completion: 4 Aug 2020 (actual)
First posted: 15 Aug 2018 (actual)
Results: Posted 12 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Active	Active comparator	Device: Relivion activeRelivion Active device
Sham	Sham comparator	Device: Relivion ShamRelivion Sham device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects 18 years of age and older.
Subject meets the ICHD (International Classification of Headache Disorders)-3 (2018) diagnostic criteria for Migraine with or without aura.
Subject reports 1-6 Migraine attacks per month; other headaches no more than 6 days per month.
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.

Key exclusion criteria (24 listed)

Subject having received Botox treatment in the head region in the prior 3 months.
Subject having received supraorbital or occipital nerve blocks in the prior month.
Past 6 months of chronic migraine, New Daily Persistent Headache, and chronic tension-type headache per ICHD-3 (2018) diagnostic criteria.
Current medication overuse headache.
Use of opioid medications in the prior 1 month.

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 active1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation	Device	Active
Relivion Sham1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation	Device	Sham

Primary outcome

Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation
Time frame: 2 hours from treatment initiation
the number and percent of subjects reporting reduction of migraine headache pain 2 hours post treatment initiation from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack (if rescue therapy was not used)

3 secondary outcomes

Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation
Time frame: 2 hours from treatment initiation
Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation
Time frame: 1 hour from treatment initiation
Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation
Time frame: 2 hours from treatment initiation

Results and safety

Results posted to the registry on 12 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active	94	67
Sham	93	64

Primary outcome: Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation

Time frame: 2 hours from treatment initiation. Count of participants. Unit: Participants

Measure	Active n = 50	Sham n = 59
Value	30	22

Active vs Sham: p = 0.018, Chi-squared

Population analysed: mITT present the number and percentage of subjects with pain relief (reduction in pain level) 2 hours post-treatment, from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated episode. If a subject had used rescue medication up to the assessment time point, he/she was considered as not reaching the endpoint. mITT set included 50 patients in the Active arm and 59 patients in the sham arm

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected per study participant from Enrollment (randomization) through study exit. ie 70 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	0 of 67 (0%)	8 of 67 (11.9%)	0 of 67
Sham	0 of 64 (0%)	2 of 64 (3.1%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35748757Tepper SJ, Grosberg B, Daniel O, Kuruvilla DE, Vainstein G, Deutsch L, Sharon R. Migraine treatment with external concurrent occipital and trigeminal neurostimulation-A randomized controlled trial. Headache. 2022 Sep;62(8):989-1001. doi: 10.1111/head.14350. Epub 2022 Jun 24.
Individual participant dataSharing planned: No

Related trials for Acute Migraine

RecruitingPhase 3
A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
Acute Migraine
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Migraine
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
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Active, not recruitingObservational study
Consistency of Response With Rimegepant in Acute Treatment of Migraine
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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, Dr. principal investigator

Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Relivion active in people with Acute Migraine, run by Neurolief Ltd. at 12 sites in 2 countries.

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 4 inclusion and 24 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: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 12 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation (time frame: 2 hours from treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03631550, which also lists 1 linked publication.

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 22 Sep 2022.