Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04334408
• Other study ID #: 18-010786
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cadasil
• Dementia, Multi-Infarct
• Migraine
• Migraine Disorders

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 2 week intervals up to 48 weeks
Primary	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.	Baseline, 2 week intervals up to 48 weeks
Primary	Adverse events	Number of adverse events reported	48 weeks

External Links

•   Mayo Clinic Clinical Trials