Functional MRI study of the central effects of erenumab in patients with episodic migraine.

Phase 1

• Conditions: Episodic migraine; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-004875-11-IT
• Lead Sponsor: OVARTIS FARMA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-07
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1) Adult patients, aged between 18 and 65 years
2) Provided informed consent
3) History of migraine with or without aura for at least 12 months prior to screening according to IHS classification ICHD-3, based on medical records and/or patient self-report
4) Migraine frequency: = 4 and < 15 migraine days per month on average across the 3 months prior to screening and confirmed during the baseline phase based on diary evaluation
5) Headache frequency: <15 headache days per month on average across the 3 months prior to screening and confirmed during the baseline phase based on diary calculation
6) Failure to 2 or more previous prophylactic treatment categories locally indicated for migraine
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 137
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1) Older than 50 years of age at migraine onset.
2) History of cluster headache or hemiplegic migraine headache.
3) History of head trauma or seizure or major psychiatric disorders.
4) Currently receiving (or have received less than 60 days or 5 half-lives prior to the start of the baseline period, during the baseline period, or treatment period) any other prophylactic treatment for migraine and/or prohibited medications, non-pharmacologic interventions or devices (any substance, non-pharmacologic intervention or device acting at central nervous system).
5) Pregnant or breastfeeding.
6) All the clinical conditions for which undergoing an MRI scan is contraindicated.

Study & Design

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