Acute Migraine Clinical Trial
Official title:
A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Performance and Safety of the Chordate System When Used in the Treatment of Acute Migraine Attacks of Moderate to Severe Intensity
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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