New Methods for Evaluating Preventive Migraine Treatment

NCT07071506 | Recruiting

• 1 other identifier: UAarhus_Chronic migraine
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to test interactions between drug and placebo-responses in acute migraine treatment and to assess variation in adverse events according to treatment information provided. Using a clinical within-subjects, balanced placebo design, patients with chronic migraine will receive four treatment conditions in a randomized order.

Conditions

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

Keywords

Headache; Chronic migraine; Balanced placebo design; Treatment effects; Adverse events

Outcome Measures

Primary Outcomes (3)

• Mean change in headache intensity

  Headache intensity rated on a 11-point Numerical Rating Scale (0=no pain; 10=worst pain intensity) measured 28 days before and after each treatment administration.

  Measured every day during the 8 month trial period

• Mean change in moderate/severe headache days

  Total number of moderate/severe headache days will be measured 28 days before and after each treatment administration. Moderate/severe headache days will be recorded by the presence of headache (yes/no), peak pain intensity (mild/moderate/severe), and duration (\< 4h or ≥ 4h), as well as acute medication intake and treatment response.

  Measured every day during the 8 month trial period

• Adverse events

  Occurrence of adverse events in each treatment condition recorded by the presence of adverse events ascribed to the treatment, measured using free recall and prompting. For each prompted symptom, participants respond "yes" or "no" and indicate whether they believe the symptom is related to the medication, the migraine attack, or another cause.

  24 hours, 14 and 28 days after each treatment administration

Secondary Outcomes (8)

• Migraine days

  Measured every day during the 8 month trial period

• Acute treatment utilization

  Measured every day during the 8 month trial period

• Positive and negative affect (PANAS)

  Pre-treatment and 28 days after each treatment administration

• Hospital Anxiety and Depression Scale (HADS)

  Pre-treatment and 28 days after each treatment administration

• Quality of life (SF-12)

  Pre-treatment and 28 days after each treatment administration

Other Outcomes (2)

• Expectations

  Weekly throughout the study period and immediately after each treatment administration

• Desire for headache relief

  28 days before treatment administration and immediately after treatment administration

Study Arms (2)

Active group

ACTIVE COMPARATOR

Active drug

Drug: Active drug for chronic migraine treatment.

Placebo group

PLACEBO COMPARATOR

Inactive placebo

Drug: Placebo Subcutaneous injection

Interventions

Placebo Subcutaneous injection DRUG

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

Placebo group

Active drug for chronic migraine treatment. DRUG

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

Active group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18-65 years)
• ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria
• 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 65
• Eligibility for preventive migraine treatment
• Ability to speak and read Danish

You may not qualify if:

• Secondary headache disorders including medication overuse headache
• Severe psychiatric, vascular disease, or known liver disease
• Alcohol abuse or substance abuse
• Current or planned pregnancy and lactation

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Department of Psychology and Behavioral sciences, Aarhus BSS, Aarhus University

Aarhus C, Denmark, 8000, Denmark

RECRUITING

Department of Neurology, Aarhus University Hospital

Aarhus N, Denmark, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lene Vase, MSc, PhD, DMSc

  Dept. of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sigrid Juhl Lunde, MSc, PhD

CONTACT

4587165956; lunde@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomized controlled cross-over design where patients receive 1\) Fremanezumab or 2) placebo, twice.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 17, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available following publication of the primary results, with no predefined end date.
• Access Criteria: Researchers upon reasonable request, subject to approval by the study investigators. Data will be shared with researchers upon reasonable request, subject to approval by the study investigators and in accordance with applicable data protection regulations. A data sharing agreement may be required.

Locations

DK (2)