We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334408
Recruitment Status : Withdrawn (Lack of funding to support the trial.)
First Posted : April 6, 2020
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
James F. Meschia, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Cadasil Migraine Drug: Fremanezumab Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024


Arm Intervention/treatment
Active Comparator: 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.
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.
Other Name: Ajovy

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.

Placebo Comparator: 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.
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.
Other Name: Ajovy

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.




Primary Outcome Measures :
  1. Change in migraine-related disability [ Time Frame: Baseline, 2 week intervals up to 48 weeks ]
    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

  2. Change in headache intensity [ Time Frame: Baseline, 2 week intervals up to 48 weeks ]
    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.

  3. Adverse events [ Time Frame: 48 weeks ]
    Number of adverse events reported



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334408


Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: James F Meschia Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: James F. Meschia, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04334408    
Other Study ID Numbers: 18-010786
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
CADASIL
Dementia, Multi-Infarct
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Cerebral Small Vessel Diseases
Dementia, Vascular
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Stroke
Dementia
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn
Infarction
Ischemia
Pathologic Processes
Necrosis
Neurocognitive Disorders
Mental Disorders