MR-Spectroscopy Study: Investigating changes in brain metabolism in migraine patients before and after therapeutic influence
- Conditions
- Episodic migraineTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2021-006219-28-AT
- Lead Sponsor
- Medical University Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 38
• Written informed consent must be obtained before any 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 = 1 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
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 38
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Older than 50 years of age at migraine onset.
• History of cluster headache or hemiplegic migraine headache
• Unable to differentiate migraine from other headaches.
• 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.
• 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.
• 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.
• 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)
• Evidence of drug or alcohol abuse or dependence in the past, based on medical records, patient self-report.
• 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.
• 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.
• Previous exposure to Fremanezumab 225mg monthly or 675mg quarterly or exposure to any other prophylactic CGRP-targeted therapy (prior to and
during the study).
• Unlikely to be able to complete all protocol required study procedures to the best of the subject’s and investigator’s knowledge
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether CGRP-antibody treatment (Fremanezumab 225mg monthly) leads to neurochemical changes in the occipital cortex and the <br>thalamus of patients with migraine with and without aura.;Secondary Objective: To identify possible correlations between disease severity, headache frequency and measured metabolic markers.;Primary end point(s): Neurochemical changes in the brain metabolism before and after CGRP antibody treatment can be detected ;Timepoint(s) of evaluation of this end point: After the second MRSI has been conducted for each patient
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Correlations between disease severity, headache frequency and measured metabolic markers can be observed.;Timepoint(s) of evaluation of this end point: After the second MRSI has been conducted for each patient