The effect of erenumab on the headache inducing properties provocation triggers in migraine patients

Phase 1

• Conditions: Migraine; MedDRA version: 20.0Level: PTClassification code 10052787Term: Migraine without auraSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10027607Term: Migraine with auraSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-000661-16-DK
• Lead Sponsor: Rigshospitalet Glostrup

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-27
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

(1) Patients with migraine with or without aura according to ICHD-3 of both sexes with a frequency of =4 migraine days per month
(2) 18-60 years old
(3) 50-100 kg weight
(4) Participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(1) Any other primary headache disorder according to ICHD-3 except for tension-type headache
(2) Any secondary headache disorder according to ICHD-3
(3) Migraine attack during the preceding 48 hours on provocation day(s)
(4) Headache during the preceding 24 hours on provocation day(s)
(4) Treatment with mAbs or participation in clinical trials with mAbs during the preceding year.
(5) Daily consumption of any other drug/medication than oral contraception (birth control)
(6) Consumption of any other drug/medication later than four times the plasma half-time of the drug on provocation day except for oral contraception.
(7) Pregnant or active breastfeeding participants.
(8) Any cardiovascular diseases including cerebrovascular disorders.
(9) Information in patient history or during physical examination indicating psychiatric disorders or substance abuse.
(10) Information in patient history or during physical examination that the screening physician deems relevant for participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified