MR-Spectroscopy: Investigating neurochemical changes in brain metabolism in migraineurs before and after CGRP-Antibody treatment – a randomized, controlled, open-label trial.

Trial details

Who runs it

Medizinische Universitaet Innsbruck

Trial code

EU 2024-517079-19-00

Record updated

2024. október 30.

Original description

To investigate whether CGRP-antibody treatment (Fremanezumab 225mg monthly) leads to neurochemical changes in the occipital cortex and the thalamus of patients with migraine with and without aura.Read full original descriptionShow less

To investigate whether CGRP-antibody treatment (Fremanezumab 225mg monthly) leads to neurochemical changes in the occipital cortex and the thalamus of patients with migraine with and without aura.

Inclusion: Written informed consent must be obtained before assessment is performed; Adults > 18 and < 65 of age upon entry into screening; Documented history of migraine with or without aura > 12 months prior to screening according to the International Classification of Headache Disorders - 3rd Edition (ICHD-3); Migraine frequency ≥ 4 and ≤ 15 migraine days per month across the 3 months prior to screening based on retrospective reporting; Subject has not received a CGRP mAB for migraine prophylaxis in the past; Subject can differentiate migraine from other headaches; Lack of contraindication for MRI.

Exclusion: Previous exposure to Fremanezumab 225mg monthly or 675mg quarterly or exposure to any other prophylactic CGRP-targeted therapy (prior to and during the study); Exposure to botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline period, during the baseline period, or treatment period; Traditional medications and/or procedures are not allowed if not used at a stable dose/frequency for at least 3 months prior to randomization and during the study; Taken the following for any indication during 2 months prior to screening: -Ergotamines or triptans on ≥10 days per month, or -NSAIDs, acetaminophen on ≥15 days per month, or -Opioid-containing analgesics on ≥4 days per month; Evidence of drug or alcohol abuse or dependence in the past, based on medical records, patient self-report; Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer; History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes; History of cluster headache or hemiplegic migraine headache; Active chronic pain syndromes (e.g., fibromyalgia, chronic pelvic pain); History of major psychiatric disorders (such as schizophrenia or bipolar disorder) or current evidence of depression; History of seizure disorder or other significant neurological conditions other than migraine; History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years; Human immunodeficiency virus (HIV) infection by history; History or evidence of any other unstable or clinically significant medical condition; Coronary artery disease, myocardial infarction, stroke, transient ischemic attack, stable or unstable angina pectoris, carotid or vertebro-basilar artery disease, other cerebrovascular conditions (e.g.: AV malformation, aneurysm); Older than 50 years of age at migraine onset; Unable to differentiate migraine from other headaches; Unlikely to be able to complete all protocol required study procedures to the best of the subject’s and investigator’s knowledge; Subject has any clinically significant vital sign during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation; Pregnant or nursing (lactating) women; Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing with study treatment.

EU CTIS 2024-517079-19-00