A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM (NCT06167655) | Clinical Trial Compass
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A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM
United States250 participantsStarted 2024-05-29
Plain-language summary
Prospective, multi-center, double blind, randomized, sham-controlled study to evaluate neuromodulation in patient with chronic migraine. The study hypothesis to be tested is the mean reduction in mean monthly headache days between patients in treatment versus sham.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. ≥ 22 years of age.
✓. Have migraine onset at ≤ 50 years of age.
✓. Have a history of migraine for ≥ 12 months prior to screening.
✓. Have 15 - 26 headache days/month, among which ≥ 8 days has the features of probable migraine, and minimum of 2 headache-free days/month during the 28-day screening period.
✓. Fulfill the criteria for chronic migraine (CM) during the 28-day screening period.
✓. Have a diagnosis of refractory chronic migraine (RCM), who have inadequate response or no access to, or are intolerant, unwilling, or contraindicated to Onabotulinum toxin A (Botox) therapy, and One of the medications that belong to Calcitonin Gene Related Peptide Monoclonal antibodies (CGRP) therapy or CGRP antagonist therapy.
✓. Maintain a stable use of preventive(s) migraine medication for ≥ 3 months before screening. Subjects receiving OnabotunlinumtoxinA must stop therapy ≥ 3 months prior to screening visit.
✓. Demonstrate ≥ 80% compliance with the headache diary during the screening period by entering headache data on a minimum of 22 out of 28 days.
Exclusion criteria
✕. Type of headache or migraine other than RCM including the following:
✕. Regular intake of opioids (including codeine) of ≥ 8 days in the past 3 months and during the 28-day screening/baseline phase and cannot be accounted for by another diagnosis.
✕. Regular intake of Barbiturates for ≥ 5 days/month in the past 3 months and during the 28-day screening/baseline phase and cannot be accounted for by another diagnosis.
✕. Report experiencing unremitting, continuous headaches with no relief.
✕. Have new daily persistent headache (NDPH) defined by iCHD-3 as persistent headache, daily from its onset, which is clearly remembered. The pain lacks characteristic features and may be migraine-like or tension-type like or have elements of both with a CM subtype.
✕. History of treatments that could confound the results of the study
✕. Previously implanted neurostimulator to stimulate the greater occipital and/or supraorbital nerves to treat headache.