E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052787 |
E.1.2 | Term | Migraine without aura |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027607 |
E.1.2 | Term | Migraine with aura |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
(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 |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
(1) Incidence of migraine-like attacks |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 7-14 Week 4, 8, 12, 16, 20, 24, 28 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |