MigraineNCT03217968
Abortive Treatment of Migraine With the Cefaly® Abortive Program Device
A study testing Cefaly® Abortive Program device in people with Migraine, run by Cefaly Technology at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Cefaly® Abortive Program device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2017to 10 Jan 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years on the day of signing the informed consent form
- ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD)-III beta (2013) section 1, migraine (8), with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
- Migraine onset before the age of 50 years
- Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening
- Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent
- Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events (AE) collecting form)
Who cannot join
- Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches
- Patient has more than 15 headache days per month
- Patient having received supraorbital nerve blocks in the prior 4 months
- Patient having received Botox treatment in the prior 4 months
- Modification of a migraine prophylaxis treatment in the previous 3 months
- Diagnosis of other primary headache disorders, except rare (< 4) tension-type headaches per month
Show all 14Show fewer
- Diagnosis of secondary headache disorders included Medication Overuse Headache
- Patients abusing opioids or user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
- Implanted metallic or electronic device in the head
- Cardiac pacemaker or implanted or wearable defibrillator
- Patient having had a previous experience with the Cefaly® device
- Migraine Aura without headache
- Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening visit (Visit 1)
- Patients not having the ability to use appropriately the device and/or to perform themselves or bear the first 20-minute stimulation session during the training session at the study site
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Clinical Research, Inc.
Rochester, New York, 14609
About this study
Official title: Abortive Treatment of Migraine With the Cefaly® Abortive Program Device: Pilot Trial
The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial.
Read the detailed description
The main objective of this study is to have a pilot assessment of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having pilot data to assess the efficacy of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.
- Conditions
- Migraine
- Being tested
- Cefaly® Abortive Program device
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefaly® Abortive Program deviceDevice
The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack Receives: Device: Cefaly® Abortive Program device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Freedom (PF) at 2 Hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
Measured: 2 hours
Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours
The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.
Measured: 2 hours
Secondary outcomes (4)
Pain Relief (PR) at 2 Hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.
Measured: 2 hours
Migraine-associated Symptoms Freedom at 2 Hours
The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session.
Measured: 2 hours
Use of Rescue Medication Between 2 and 24 Hours
The percentage of patients who took acute anti-migraine medication between 2 and 24 hours after the beginning of the e-TNS session.
Measured: Between 2 and 24 hours
Sustained Pain Freedom at 24 Hours
The percentage of patients having no headache (Grade 0) at 2 hours, with no use of rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start10 Aug 2017
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
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.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cefaly Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph MANN, M.D., Principal investigator, Rochester Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217968
- Sponsor's protocol ID
- 50803
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2017
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- 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 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abortive Treatment of Migraine With the Cefaly® Abortive Program Device: Pilot Trial
- ClinicalTrials.gov ID
- NCT03217968
- Acronym / sponsor ID
- 50803
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Cefaly TechnologyIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Posted 7 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial.
Detailed description
The main objective of this study is to have a pilot assessment of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having pilot data to assess the efficacy of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Cefaly® Abortive Program device120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 18 to 65 years on the day of signing the informed consent form
- ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD)-III beta (2013) section 1, migraine (8), with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
- Migraine onset before the age of 50 years
- Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening
- Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent
Key exclusion criteria (14 listed)
- Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches
- Patient has more than 15 headache days per month
- Patient having received supraorbital nerve blocks in the prior 4 months
- Patient having received Botox treatment in the prior 4 months
- Modification of a migraine prophylaxis treatment in the previous 3 months
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 |
|---|---|---|
| Cefaly® Abortive Program deviceThe Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). | Device | Active |
Primary outcome
Pain Freedom (PF) at 2 Hours
Time frame: 2 hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours
Time frame: 2 hours
The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.
4 secondary outcomes
Pain Relief (PR) at 2 Hours
Time frame: 2 hours
Migraine-associated Symptoms Freedom at 2 Hours
Time frame: 2 hours
Use of Rescue Medication Between 2 and 24 Hours
Time frame: Between 2 and 24 hours
Sustained Pain Freedom at 24 Hours
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Joseph MANN, M.D. principal investigator
Rochester Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefaly® Abortive Program device in people with Migraine, run by Cefaly Technology at 1 site in United States.
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 6 inclusion and 14 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 7 Jun 2018). 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?
Pain Freedom (PF) at 2 Hours (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 7 Aug 2018.