Status:
UNKNOWN
The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients
Lead Sponsor:
Danish Headache Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Migraine
Migraine Without Aura
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
A randomized, double-blind, placebo-controlled, parallel study to investigate the effect of erenumab in calcitonin-gene related peptide and cilostazol experimental models of migraine in humans. Follow...
Eligibility Criteria
Inclusion
- Patients with migraine with or without aura according to the International Classification of Headache Disorders with a frequency of ≥4 migraine days per month
- 50-100 kg weight
- Participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent
Exclusion
- Any other primary headache disorder according to the International Classification of Headache Disorders except for tension-type headache
- Any secondary headache disorder according to the International Classification of Headache Disorders
- Migraine attack during the preceding 48 hours on provocation day
- Headache during the preceding 24 hours on provocation day
- Treatment with monoclonal antibodies or participation in clinical trials with monoclonal antibodies during the preceding year
- Daily consumption of any other drug/medication than oral contraception (birth control)
- Consumption of any other drug/medication later than four times the plasma half-time of the drug on provocation day except for oral contraception
- Pregnant or active breastfeeding participants
- Any cardiovascular diseases including cerebrovascular disorders
- Information in patient history or during physical examination indicating psychiatric disorders or substance abuse
- Information in patient history or during physical examination that the screening physician deems relevant for participation in the study
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04452929
Start Date
July 22 2020
End Date
July 1 2022
Last Update
October 8 2020
Active Locations (1)
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1
Danish Headache Center
Glostrup Municipality, Denmark, 2600