Episodic migraine
Conditions
Interventions
Trade Name: Ajovy
Product Name: Ajovy
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Fremanezumab
CAS Number: 1655501-53-3
Concentration unit: mg milligram(s)
C
Sponsors
Medical University Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent must be obtained before any assessment is performed • Adults > 18 and 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria
Contacts
Public ContactKopfschmerzambulanz
Univ. Clinic Innsbruck, Department of Neurology
Outcome results
None listed