The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients
NCT ID: NCT04452929
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2020-07-22
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Randomized treatment phase: Erenumab
Erenumab 140 mg single subcutaneous injection at baseline
Erenumab
Subcutaneous injection of 140 mg erenumab.
Calcitonin gene-related peptide
Intravenous infusion of 1.5ug/min calcitonin gene-related peptide over 20 minutes.
Cilostazol
Oral intake of 200 mg cilostazol.
Randomized treatment phase: Placebo
Saline placebo single subcutaneous injection at baseline
Placebo
Subcutaneous injection of saline placebo.
Calcitonin gene-related peptide
Intravenous infusion of 1.5ug/min calcitonin gene-related peptide over 20 minutes.
Cilostazol
Oral intake of 200 mg cilostazol.
Open-label extension treatment phase: Erenumab
Erenumab 140 mg monthly subcutaneous injection for six months after completion of the randomized, double-blinded, placebo-controlled study phase during the open-label extension
Erenumab
Subcutaneous injection of 140 mg erenumab.
Interventions
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Erenumab
Subcutaneous injection of 140 mg erenumab.
Placebo
Subcutaneous injection of saline placebo.
Calcitonin gene-related peptide
Intravenous infusion of 1.5ug/min calcitonin gene-related peptide over 20 minutes.
Cilostazol
Oral intake of 200 mg cilostazol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 50-100 kg weight
* Participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Danish Headache Center
OTHER
Responsible Party
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Messoud Ashina
Principal Investigator
Principal Investigators
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Thien P Do, MD
Role: STUDY_DIRECTOR
Danish Headache Center
Locations
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Danish Headache Center
Glostrup Municipality, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CGRP2020
Identifier Type: -
Identifier Source: org_study_id
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