Migraine MedDRA version: 20.0 Level: PT Classification code 10052787 Term: Migraine without aura System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10027607 Term: Migraine with aura System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Aimovig
Pharmaceutical Form: Injection
INN or Proposed INN: ERENUMAB
CAS Number: 1582205-90-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration numb
Sponsors
Rigshospitalet Glostrup
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) To investigate the effect of anti-CGRP receptor monoclonal antibody (mAb), erenumab, in prevention of CGRP-induced and cilostazol-induced migraine-like attacks in patients with migraine (2) To investigate the effect of anti-CGRP receptor mAb, erenumab, in prevention of CGRP-induced and cilostazol-induced dilation of extracerebral arteries in patients with migraine (3) To investigate the effect of anti-CGRP receptor mAb, erenumab, in preventing CGRP-induced and cilostazol-induced facial flushing in patients with migraine (4) To investigate the effect of anti-CGRP receptor mAb, erenumab, on peptide blood levels in patients with migraine ;Secondary Objective: Not applicable;Primary end point(s): (1) Incidence of migraine-like attacks ;Timepoint(s) of evaluation of this end point: Day 7-14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Intensity of headache (2) Diameter of superficial temporal artery and radial artery (3) Plasma concentrations of CGRP, PACAP and VIP (4) Responder rate defined as =50% reduction in migraine days frequency (5) Change in monthly migraine headache days (6) Change in monthly migraine attacks (7) Incidence of facial flushing (8) Facial blood flow changes;Timepoint(s) of evaluation of this end point: Day 7-14 Week 4, 8, 12, 16, 20, 24, 28 | — |
Countries
Denmark
Contacts
Public ContactThien Phu Do
Rigshospitalet Glostrup
Outcome results
None listed