The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients

Danish Headache Center

Status: Unknown

Conditions: Migraine With Aura; Migraine Without Aura; Migraine

Treatments: Drug: Calcitonin gene-related peptide; Drug: Cilostazol; Drug: Placebo; Drug: Erenumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04452929

CGRP2020

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups, including a placebo group

Randomized treatment phase: Erenumab

Active Comparator group

Description:

Erenumab 140 mg single subcutaneous injection at baseline

Treatment:

Drug: Erenumab

Drug: Calcitonin gene-related peptide

Drug: Cilostazol

Randomized treatment phase: Placebo

Placebo Comparator group

Description:

Saline placebo single subcutaneous injection at baseline

Treatment:

Drug: Placebo

Drug: Calcitonin gene-related peptide

Drug: Cilostazol

Open-label extension treatment phase: Erenumab

Other group

Description:

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

Treatment:

Drug: Erenumab