Migraine Clinical Trial
Official title:
Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
To explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | August 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Age = 18 years of age upon entry into screening - History of migraine with or without aura for = 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria - = 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening - Subject has provided informed consent prior to initiation of any study-specific activities/procedures. - Must have demonstrated greater than or equal to 75% compliance in Headache Diary usage during the 4-week run-period prior to Day 1 of the open-label treatment phase. Exclusion Criteria: - > 50 years of age at migraine onset - History of cluster headache or hemiplegic migraine - Inability to differentiate migraine from other headaches - The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior - History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion - Previously received erenumab (Aimovig) - Received anti-CGRP monoclonal antibody within 3 months prior to the CGRP-infusion - Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. - Female subjects of childbearing potential with a positive pregnancy test during any study visit - Female subject is pregnant or breastfeeding or planning to become pregnant during the study - Evidence of current pregnancy or breastfeeding - Female subject of childbearing potential unwilling to use an acceptable method of effective contraception - Hypertension on the experimental day defined as systolic blood pressure = 150mmHg or diastolic blood pressure = 100mmHg - Hypotension on the experimental day defined as systolic blood pressure < 90mmHg or diastolic blood pressure < 50mmHg - Any headache (including migraine) within 24 hours prior to the start of the CGRP-infusion - Intake of any analgesics or migraine-specific medications within 24 hours prior to the start of the CGRP-infusion - Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required study procedures to the best of the subject and study investigator's knowledge |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Headache Center | Copenhagen | Glostrup |
Lead Sponsor | Collaborator |
---|---|
Danish Headache Center |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Headache Diary (Baseline Phase and Treatment Phase) | Headache diary with daily entries to record migraine-related data (e.g. migraine days, headache days, number of days with use of acute migraine medication, number of days with aura). | Baseline Phase (Day -28 to Day 1) to Week 24 | |
Secondary | Headache Diary (Provocation Phase) | Subjects will be instructed to fill out a headache diary during the 12-hour observational period. The diary will be used to record migraine-related data (e.g. location, quality, intensity, aggravation by routine physical activity, use of acute migraine medication, nausea, vomiting, photophobia, and phonophobia) | Provocation Phase (12 Hours) | |
Secondary | Semi-Structured Interview | In-person semi-structured interview to record migraine-related data (e.g. location, quality, intensity, aggravation by routine physical activity, use of acute migraine medication, nausea, vomiting, photophobia, phonophobia, premonitory symptoms, postdromal symptoms, trigger factors, autonomic symptoms). | 1 Hour |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05525611 -
Cabergoline as a Preventive Treatment for Chronic Migraine
|
N/A | |
Completed |
NCT06192173 -
Patent Foramen Ovale Closure in Migraine
|
||
Recruiting |
NCT03832998 -
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
|
Phase 3 | |
Enrolling by invitation |
NCT04196933 -
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma
|
N/A | |
Not yet recruiting |
NCT06428838 -
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
|
Phase 3 | |
Completed |
NCT06304675 -
Manageable Environmental Factors in Migraine
|
||
Completed |
NCT04084314 -
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
|
Phase 4 | |
Recruiting |
NCT05517200 -
Pilot Study for a Machine Learning Test for Migraine
|
||
Completed |
NCT04179474 -
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
|
Phase 1 | |
Recruiting |
NCT04603976 -
Registry for Migraine - Clinical Core
|
Phase 4 | |
Completed |
NCT03597529 -
CHOCOlate MeLatonin for AdolescenT MigrainE
|
Phase 2 | |
Completed |
NCT04197349 -
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
|
Phase 1 | |
Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
Active, not recruiting |
NCT05064371 -
Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan
|
Phase 3 | |
Suspended |
NCT04069572 -
Vibratory Stimulation for the Treatment of Chronic Pain
|
N/A | |
Not yet recruiting |
NCT04859374 -
Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach
|
N/A | |
Not yet recruiting |
NCT03083860 -
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
|
N/A | |
Completed |
NCT02905227 -
A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
|
Phase 1 | |
Enrolling by invitation |
NCT02532023 -
The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients
|
Phase 4 | |
Completed |
NCT02108678 -
One-Day Intervention for Depression and Impairment in Migraine Patients
|
N/A |