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

NCT04452929 | Unknown DMC

• 1 other identifier: CGRP2020
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Migraine Without Aura; Migraine With Aura

Outcome Measures

Primary Outcomes (1)

• Migraine-like attack

  The incidence of migraine-like attack after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. A migraine-like attack is defined attack fulfilling either (i) or (ii): (i) Headache fulfilling criteria C and D for migraine without aura according to the International Headache Society criteria: C. Headache has at least two of the following characteristics: unilateral location; pulsating quality; moderate or severe pain intensity (moderate to severe pain intensity is considered ≥4 on verbal rating scale); aggravation by cough (in-hospital phase) or causing avoidance of routine physical activity (out-hospital phase); D. During headache at least one of the following: nausea and/or vomiting; photophobia and phonophobia; and (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).

  Before (-5 min) and after administration of (+12 hours) of experimental trigger

Secondary Outcomes (11)

• Headache intensity

  Before (-5 min) and after administration of (+12 hours) of experimental trigger

• Hemodynamics (superficial temporal artery)

  Before (-5 min) and after administration of (+90 minutes) of experimental trigger

• Hemodynamics (radial artery)

  Before (-5 min) and after administration of (+90 minutes) of experimental trigger

• Neuropeptide plasma concentrations (CGRP)

  (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase

• Neuropeptide plasma concentrations (VIP)

  (1) Before (-5 min) and after administration of (+60 minutes) of experimental trigger; (2) 24-week open-label treatment phase

Study Arms (3)

Randomized treatment phase: Erenumab

ACTIVE COMPARATOR

Erenumab 140 mg single subcutaneous injection at baseline

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

Randomized treatment phase: Placebo

PLACEBO COMPARATOR

Saline placebo single subcutaneous injection at baseline

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

Open-label extension treatment phase: Erenumab

OTHER

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

Drug: Erenumab

Interventions

Erenumab DRUG

Subcutaneous injection of 140 mg erenumab.

Also known as: Aimovig®

Open-label extension treatment phase: Erenumab; Randomized treatment phase: Erenumab

Placebo DRUG

Subcutaneous injection of saline placebo.

Also known as: Saline placebo

Randomized treatment phase: Placebo

Calcitonin gene-related peptide DRUG

Intravenous infusion of 1.5ug/min calcitonin gene-related peptide over 20 minutes.

Randomized treatment phase: Erenumab; Randomized treatment phase: Placebo

Cilostazol DRUG

Oral intake of 200 mg cilostazol.

Randomized treatment phase: Erenumab; Randomized treatment phase: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with migraine with or without aura according to the International Classification of Headache Disorders with a frequency of ≥4 migraine days per month
• kg weight
• Participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Migraine without Aura; Migraine with Aura

Interventions

erenumab; Calcitonin Gene-Related Peptide; Cilostazol

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Thien P Do, MD

  Danish Headache Center

  STUDY DIRECTOR

Central Study Contacts

Thien P Do, MD

CONTACT

004541414117; tdoo0001@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double-blinded, placebo-controlled, parallel study followed by a 6-month open-label extension.

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 1, 2020
• Study Start: July 22, 2020
• Primary Completion: February 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)