Subjects that have been diagnosed with both CADASIL and moderately to severely disabling migraine headaches will be treated with Fremanezumab injections.

Subjects that have been diagnosed with both CADASIL and moderately to severely disabling migraine headaches will be treated with placebo injections.

Cadasil

Migraine

Subjects will receive a single dose total 225 mg (1 injection of 225 mg per 1.5 mL injection) followed by a single dose of 225 mg (1 1.5mL injection) at four week intervals. Both the subject and the investigator will be blinded to the timing of transition to and from placebo and the transition to and from fremanezumab.

Fremanezumab

Placebo injections during the run in and washout serves as the control condition. Both the subject and the investigator will be blinded to the timing of transition to and from placebo and the transition to and from fremanezumab.

Placebo

Mayo Clinic in Florida

Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

A Phase II Double-Blinded Placebo Controlled Individual Subject Stepped Wedge Clinical Trial Evaluating the Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

Measured using the The Migraine Disability Assessment (MIDAS) questionnaire which is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period using number of days

Measured using Headache Impact Test (HIT)-6 scores with the answers being never, rarely, sometimes, very often or always and equating to 6, 8, 10, 11, and 13 points respectively. Each answer is summated to equal the final score.

James F. Meschia

Principal Investigator

Mayo Clinic

Ischemic Stroke

Hanyang University

Stroke in Korean Young Adults Study

Information will be obtained from participant's last practitioner or care-giver.

Minimum necessary time interval between original event and recurrent stoke is 21 days. If a stroke occured within 21 days, it has to be located in the different vascular territory as the original event.

Subsequent fatal or nonfatal myocardial infarction

Two or more unprovoked epileptic seizures occuring at ≥1 week after the ischemic stroke event.

Young Seo Kim

Professor

Hallym University Medical Center

Seoul National University Hospital

Seoul National University Bundang Hospital

Severance Hospital

Seoul National University Boramae Hospital

Kyung Hee University Hospital

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Cerebrovascular Research Club

CADASIL

NYU School of Medicine

Research Study on Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)

Natural History of CADASIL: Migraine, Diagnosis and Misdiagnosis

We sent a questionnaire to CADASIL subjects upon their consent to enroll in the study. The questionnaire addressed the history of migraine in till the time of enrollment. Other features such as history of stroke, memory involvement till enrollment was assessed in the questionnaire. The study aims at comparing the two groups- subjects with migraine and without migraine.

cadasil/headache

Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

Stroke in Korean Young Adults Study

Research Study on Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)

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