Status:
WITHDRAWN
Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL
Lead Sponsor:
Mayo Clinic
Conditions:
Cadasil
Migraine
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Researchers are trying to find out more about the side effects of fremanezumab when treating patients with Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (C...
Detailed Description
Subjects will receive 4 to 20 weeks of placebo injections followed by 12 weeks of monthly administered fremanezumab by subcutaneous injection (225 mg split four weeks apart for 12 weeks). Following co...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 18 to 70 years old
- English speaking
- Diagnosis of CADASIL confirmed by presence of a pathogenic NOTCH3 gene mutation
- Diagnosis of migraine for at least 12 months and diagnosis of chronic migraine for at least 28 days according to the International Classification of Headache Disorders
- MIDAS score of \>10 points
- Ability to provide written informed consent
- Exclusion Criteria
- History of ischemic stroke within 4 weeks of screening assessment
- Screening blood pressure \>150 mm Hg
- Use of onabotulinum toxin A 4 months prior to trial or other injectable/stimulatory/magnetic method of headache control
- Use of opiates or barbiturates 4 days prior to trial
- Patients with competing intracerebral pathology (e.g. history of intracerebral hemorrhage, multiple sclerosis)
- NYHA Class III or IV congestive heart failure
- History of myocardial infarction
- History of coronary bypass surgery or coronary stenting
- Pregnancy or breastfeeding
- Contraindication to undergoing brain MRI per standard clinical practice guidelines
- Vulnerable populations, including incarcerated inmates, dementia, and inability to provide consent
Exclusion
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04334408
Start Date
December 1 2021
End Date
December 1 2024
Last Update
February 28 2022
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