High-frequency episodic migraine. MedDRA version: 22.0 Level: LLT Classification code 10082019 Term: Episodic migraine System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Emgality
Pharmaceutical Form: Injection
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that a 3 months treatment with Galcanezumab results in structural and functional brain alterations and changes of CGRP blood levels in patients with high-frequency episodic migraine. The purpose of this study is to identify structural and functional neuroimaging and laboratory biomarkers (CGRP / PACAP, immune cell populations) that are altered in association with treatment with Galcanezumab in patients with high frequency episodic migraine. Data from this study will provide information on neuroimaging and blood markers that may help to identify patients who benefit from a prophylactic treatment with Galcanezumab. ;Secondary Objective: 1. To evaluate if neuroimaging and blood markers alterations in patients with high-frequency episodic migraine treated with Galcanezumab differ between treatment responders and non-responders (=50% Response vs. <50% Response) 2. To evaluate if changes of neuroimaging and blood biomarkers in patients with high-frequency episodic migraine correlate with changes of monthly migraine days in response to treatment with Galcanezumab ;Primary end point(s): Functional brain alterations (rs-fMRI) after 3 months treatment with Galcanezumab in patients with high-frequency episodic migraine;Timepoint(s) of evaluation of this end point: week 12/month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Structural brain alterations (VBM, DTI) after 3 months treatment with Galcanezumab 2) Mean CGRP (calcitonin gene-related peptide) plasma and tear fluid concentrations after 3 months treatment with Galcanezumab 3) Structural and functional brain alterations at baseline and after 3 months treatment in responders (reduction from baseline =50% in monthly migraine days in month 3) in comparison to non-responders (reduction from baseline <50% in monthly migraine days in month 3) 4) Mean concentrations of CGRP and PACAP (calcitonin gene-related peptide) at baseline and month 3 in responders in comparison to non-responders 5) Peripheral immune cell subpopulations and levels of cytokines (IL-1ß, IL-6, TNF-a) at baseline and after the 3 months treatment 6) Structural and functional brain alterations and change in CGRP and PACAP levels in patients in comparison to healthy controls ;Timepoint(s) of evaluation of this end point: month 3 (day 75 +/-7) | — |
Countries
Germany
Contacts
Public ContactStudy Physician
Charité - Universitätsmedizin Berlin
Outcome results
None listed