Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

NCT ID: NCT04334408

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2024-12-31

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 (CADASIL) for migraine headaches.

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 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.

Conditions

Cadasil; Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Subjects with CADASIL treatment intervention

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

Group Type: ACTIVE_COMPARATOR

Fremanezumab

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

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.

Subjects with CADASIL placebo intervention

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

Group Type: PLACEBO_COMPARATOR

Fremanezumab

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

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.

Interventions

Fremanezumab

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

Ajovy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

James F. Meschia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James F Meschia

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

18-010786

Identifier Type: -

Identifier Source: org_study_id