New Methods for Evaluating Preventive Migraine Treatment
NCT ID: NCT07071506
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-03-04
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
1\) Fremanezumab or 2) placebo, twice.
BASIC_SCIENCE
DOUBLE
Study Groups
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Active group
Active drug
Active drug for chronic migraine treatment.
Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously
Placebo group
Inactive placebo
Placebo Subcutaneous injection
Inactive placebo (saline) injected subcutaneously in the same volume as the active drug
Interventions
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Active drug for chronic migraine treatment.
Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously
Placebo Subcutaneous injection
Inactive placebo (saline) injected subcutaneously in the same volume as the active drug
Eligibility Criteria
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Inclusion Criteria
2. ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria
3. Known chronic migraine (headache occurring ≥ 15 days per month for \> 3 months, which on at least 8 days per month has the features of migraine headache) diagnosed before age 50
4. Qualifying for preventive migraine treatment (screened by neurologist)
5. Ability to speak and read Danish
Exclusion Criteria
2. Use of other preventive migraine treatment other than CGRP antagonists (However, participants are allowed to be on one stable preventive medication (antidepressant, calcium channel blockers, beta blockers or antiepileptic)- 2 months prior to screening until end of study , if necessary), devices for migraine prevention such as transcranial magnetic stimulation and use of nerve blocks 3 months prior to screening
3. Use of opioid or barbiturate medications in the last four weeks before participation in the study
4. Secondary headache disorders including medication overuse headache
5. Severe psychiatric, vascular disease, or known liver disease
6. Alcohol abuse, drug abuse, or substance abuse
7. Current or planned pregnancy and lactation
18 Years
65 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Lene Vase, MSc, PhD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Dept. of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark
Locations
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Department of Psychology and Behavioral sciences, Aarhus BSS, Aarhus University
Aarhus C, Denmark, Denmark
Department of Clinical Medicine, Aarhus University Hospital
Aarhus N, Denmark, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UAarhus_Chronic migraine
Identifier Type: -
Identifier Source: org_study_id
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