Clinical trial NCT04452929: The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients
Official title: The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Migraine Without Aura
Migraine With Aura
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2020-07-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blinded, placebo-controlled, parallel study followed by a 6-month open-label extension.
Primary purpose: HEALTH_SERVICES_RESEARCH

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. Followed by a 6-month open-label extension.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Migraine-like attack
timeFrame: Before (-5 min) and after administration of (+12 hours) of experimental trigger
Secondary outcomes:
measure: Headache intensity
timeFrame: Before (-5 min) and after administration of (+12 hours) of experimental trigger
measure: Hemodynamics (superficial temporal artery)
timeFrame: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
measure: Hemodynamics (radial artery)
timeFrame: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
measure: Neuropeptide plasma concentrations (CGRP)
timeFrame: (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase
measure: Neuropeptide plasma concentrations (VIP)
timeFrame: (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase
measure: Neuropeptide plasma concentrations (PACAP)
timeFrame: (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase
measure: Facial flushing
timeFrame: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
measure: Facial temperature
timeFrame: Before (-5 min) and after administration of (+90 minutes) of experimental trigger
measure: Headache day
timeFrame: Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase
measure: Migraine day
timeFrame: Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase
measure: ≥50% responder rate
timeFrame: Baseline and the last 3 months (months 4, 5, and 6) of the 24-week open-label treatment phase
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
affiliation: Danish Headache Center
name: Thien P Do, MD
role: STUDY_DIRECTOR
References: