New Methods for Evaluating Preventive Migraine Treatment

NCT ID: NCT07071506

Last Updated: 2025-07-17

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-04

Study Completion Date

2028-09-30

Brief Summary

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The study aims to estimate treatment effects in a balanced placebo design (BPD) to specify to which extent contextual factors interact in preventive migraine treatment and influence adverse event occurrence in patients with chronic migraine. Using a clinical within-subjects design, patients with chronic migraine will receive four treatment conditions in a randomized order.

Detailed Description

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The existing paradigm for testing the effect of treatment is the double-blind RCT comparing an active drug to an inactive placebo. This comparison is done in order to control for contextual and psychological factors such as the patients' treatment expectations - a key factor in placebo responses. However, recent studies have indicated that some assumptions underlying the RCT may be incorrect and may lower the assay sensitivity and miscalculate the actual drug response. The so-called balanced placebo design targets some of the shortcomings of the RCT by balancing the information given to the patients with the actual treatment administered. In this project, patients suffering from chronic migraine will receive a total of 4 injections over 8 months. Half of them are femanezumab, while the other half are placebo (an inactive injection). The injections (fremanezumab and placebo) look the same, and neither the patient nor the investigator know which injection will be administered. The order will be randomized. The injections are given with different information about what the patients are receiving. To avoid a carry-over effect, the patients will receive one injection every second month. The first month will be without treatment whereupon the patient will receive the first injection. During the first 28 days before and after each administration, patients rate outcome measures in an electronic pain/headache diary at home. In addition, they will also fill out questionnaires assessing their quality of life, psychological parameters and the headache burden.

Conditions

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Migraine Migraine With or Without Aura Headache Disorders Chronic Migraine, Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blinded randomized controlled cross-over design where patients receive

1\) Fremanezumab or 2) placebo, twice.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active group

Active drug

Group Type ACTIVE_COMPARATOR

Active drug for chronic migraine treatment.

Intervention Type DRUG

Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously

Placebo group

Inactive placebo

Group Type PLACEBO_COMPARATOR

Placebo Subcutaneous injection

Intervention Type DRUG

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

Intervention Type DRUG

Placebo Subcutaneous injection

Inactive placebo (saline) injected subcutaneously in the same volume as the active drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adults (18-65 years)
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

1. Use of onabotulinumtoxinA as preventive migraine treatment during the 4 months before screening
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Department of Clinical Medicine, Aarhus University Hospital

Aarhus N, Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Simple Futarmal Kothari, BDS, MSc, PhD

Role: CONTACT

004550395697

Sigrid Juhl Lunde, MSc, PhD

Role: CONTACT

4587165956

Facility Contacts

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Simple Futarmal Kothari, BDS, MSc, PhD

Role: primary

004550395697

Lene Vase, MSc, PhD, DMSc

Role: backup

004530614476

Simple Futarmal Kothari

Role: primary

004550395697

Lene Vase

Role: backup

004530614476

Other Identifiers

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UAarhus_Chronic migraine

Identifier Type: -

Identifier Source: org_study_id

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