Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mayo Clinic
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.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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