Migraine
Conditions
Brief 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.
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.
Interventions
DEVICECefaly® Abortive Program device
The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).
Sponsors
Cefaly Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Freedom (PF) at 2 Hours | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief (PR) at 2 Hours | 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. |
| Migraine-associated Symptoms Freedom at 2 Hours | 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. |
| Use of Rescue Medication Between 2 and 24 Hours | 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. |
| Sustained Pain Freedom at 24 Hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack
Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Active | — |
|---|---|---|
| Age, Continuous | 46.85 years STANDARD_DEVIATION 10.2 | — |
| Migraine intensity Moderate intensity at baseline | 33 Participants | — |
| Migraine intensity Severe intensity at baseline | 15 Participants | — |
| Migraine type Migraine with aura | 15 Participants | — |
| Migraine type Migraine without aura | 33 Participants | — |
| Most bothersome syndrome Nausea | 11 Participants | — |
| Most bothersome syndrome Sensitivity to light | 27 Participants | — |
| Most bothersome syndrome Sensitivity to sound | 9 Participants | — |
| Most bothersome syndrome Vomiting | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 43 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 59 |
| other Total, other adverse events | 15 / 59 |
| serious Total, serious adverse events | 0 / 59 |
Outcome results
Primary
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.
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours | 29 Participants |
Primary
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.
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | Pain Freedom (PF) at 2 Hours | 17 Participants |
Secondary
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.
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | Migraine-associated Symptoms Freedom at 2 Hours | 22 Participants |
Secondary
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.
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | Pain Relief (PR) at 2 Hours | 34 Participants |
Secondary
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.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | Sustained Pain Freedom at 24 Hours | 12 Participants |
Secondary
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.
Time frame: Between 2 and 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | Use of Rescue Medication Between 2 and 24 Hours | 24 Participants |