Acute Migraine
Conditions
Brief summary
The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.
Detailed description
One single migraine attack will be treated either with the Chordate System S020 or with Chordate System in placebo mode. After a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.
Interventions
DEVICEChordate System S020 in treatment mode
DEVICEChordate System S020 in placebo mode
Sponsors
Chordate Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with migraine, with or without aura according to International Headache Society (IHS) classification (International Classification of Headache Disorders \[ICHD\]-III beta). * History of 1 to 6 migraine attacks per month for at least 12 previous months. * At least 50% of previous migraine attacks had moderate or severe pain intensity. * History of at least 48 hours of freedom from headache between migraine attacks. * The majority of the previous untreated migraine attacks lasted at least 8 hours. * Migraine onset before the age of 50 years.
Exclusion criteria
* History (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind). * More than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation). * Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack. * Treatment with Botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit. * Previously treated with an implantable stimulator or any implantable devices in the head and/or neck. * Pronounced anterior septal nasal deviation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache relief | 2 hours after treatment initiation | Percentage of subjects with a decrease in migraine headache pain from severe or moderate prior treatment to mild or none at 2 hours after treatment initiation with no use of rescue medication during this time period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of recurrence | 48 hours after treatment initiation | — |
| 24 hour sustained pain-free rate | 24 hours after treatment initiation | percentage of subjects remaining pain-free |
| Subject global impression | 48 hours post-treatment initiation. | — |
| Use of rescue medication | 48 hours post-treatment initiation | — |
| Pain-free rate | 2 hours after treatment initiation | Percentage of subjects pain-free (pain intensity rated 'No pain') at 2 hours after treatment initiation with no use of rescue medication. |
| 48 hour sustained pain-free rate | 48 hours after treatment initiation | percentage of subjects remaining pain-free |
| Time to meaningful relief | 4 hours post-treatment initiation | — |
| Change in nausea, photophobia, phonophobia, vomiting and disability | 2 hours post-treatment initiation | — |
| Frequency, severity, device-relationship and outcome of all adverse events | 48 hours post-treatment initiation | — |
Countries
Germany
Outcome results
None listed