Study with the objective to find in patients with high-frequency episodic migraine (patients with 8-14 migraine days/months) signs on head MRI (=neuroimaging biomarkers) and indicators from blood and tear fluid (=laboratory biomarkers) which are linked to a good efficacy of a medication named Galcanezumab

Phase 1

• Conditions: High-frequency episodic migraine.; MedDRA version: 22.0Level: LLTClassification code 10082019Term: Episodic migraineSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-006176-16-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-04
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

At Screening:
•Adults =18 and = 65 years of age upon entry into screening
•Diagnosis of episodic migraine according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (21) with a history of migraine headaches of at least 1 year prior to Visit 1
•History of episodic migraine with 8-14 migraine days / month on average within the past 3 months
•Migraine onset prior to age 50
•Capability of understanding the nature, significance and implications of the clinical trial. Written informed consent must be obtained before any assessment is performed
•Reliable and willing to follow study procedures
•Valid health insurance (to assure medical clarification in case of incidental findings on MRI)
During Baseline:
•This inclusion criterion should not be shared with potential patients: 8-14 migraine days / month during baseline (-30 days before first treatment)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 89
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Current participation or participation within the last 30 days or within 5 half-lives (whichever is longer) in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
•Current use of a prohibited treatment (pharmaceutical or neurostimulation) for the prevention of migraine
•Current use of an effective and well tolerated treatment (pharmaceutical or neurostimulation) for the prevention of migraine. Insufficient efficacy and tolerability as determined by the patient
•Current use or prior exposure to any CGRP (receptor) antibody
•Diagnosis or history of other primary headache diseases according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), except for episodic tension-type headache
•Systemic or metabolic disorder including high blood pressure severe hypertension (not medically controlled or taking more than one drug class for treatment, diabetes mellitus, or hypercholesterolemia (not controlled by medical treatment and/or diet)
•History or current severe coronary artery disease, myocardial infarction, stroke, transient ischemic attack, unstable angina, deep vein thrombosis, coronary artery bypass surgery or other revascularization procedures within 12 months prior to screening
•Planned cardiovascular surgery or percutaneous coronary angioplasty
•History or presence of any other medical illness including but not limited to any autoimmune disorder, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality, that in the judgment of the investigator, indicates a medical problem that would preclude study participation.
•Psychiatric disease besides stable panic disorder or depression (not more than one 1 medication and no increase in dosage or restarting of treatment within the 3 months prior to the start of the baseline phase)
•History of drug or alcohol abuse/dependence within 1 year prior to inclusion
•Pregnancy / planned pregnancy, nursing patients
•Contraindication for MRI
•Radiological exclusion criteria: ischemic or hemorrhagic lesions, tumor, and intracranial cyst

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified