New Methods for Evaluating Preventive Migraine Treatment

University of Aarhus

Status: Enrolling

Conditions: Headache Disorders; Chronic Migraine, Headache; Migraine; Migraine With or Without Aura

Treatments: Drug: Placebo Subcutaneous injection; Drug: Active drug for chronic migraine treatment.

Study type: Interventional

Funder types: Other

Identifiers

NCT07071506

UAarhus_Chronic migraine

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Active group

Active Comparator group

Description:

Active drug

Treatment:

Drug: Active drug for chronic migraine treatment.

Placebo group

Placebo Comparator group

Description:

Inactive placebo

Treatment:

Drug: Placebo Subcutaneous injection