Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

Brief Title

Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in migraine-related disability


Condition

Cadasil

Intervention

Fremanezumab

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

5

Start Date

January 2021

Completion Date

December 2024

Primary Completion Date

December 2024

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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

James F Meschia, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04334408

Organization ID

18-010786


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic


Study Sponsor

James F Meschia, Principal Investigator, Mayo Clinic


Verification Date

April 2020