Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

Mayo Clinic

Overview

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 (CADASIL) for migraine headaches.

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 completion of the 12 weeks of therapy, the participant will return to placebo for the washout period. Both the patient and the investigator will be blinded to the timing of transition to and from placebo and the transition to and from fremanezumab.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Cadasil Migraine

Interventions

FremanezumabDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in migraine-related disability

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

Time frame: Baseline, 2 week intervals up to 48 weeks

Change in headache intensity

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.

Time frame: Baseline, 2 week intervals up to 48 weeks

Adverse events

Number of adverse events reported

Time frame: 48 weeks

Data from ClinicalTrials.gov

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