Changes in advance MRI on migraine patients treated with fremanezumab

Phase 1

• Conditions: MIGRAINE; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 100000004852

• Registration Number: EUCTR2020-004509-30-ES
• Lead Sponsor: INSTITUTO DE ESTUDIOS DE CIENCIAS DE LA SALUD DE CASTILLA Y LEO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

1.Definite diagnosis of Migraine With Aura or Migraine Without Aura
according to the International Classification of Headache Disorders, 3rd
version (IHCD-3) (1).
2.Age between 18 and 65 years old.
3.Providing signed informed consent form.
4.Diagnosis of migraine before 50 years old.
5.History of migraine during at least 12 months prior to the study.
6.With eight or more migraine days per month within the last three
months.
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 87
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Presence of other primary headache disorders other than infrequent
tension-type headache or medication overuse headache (MOH).
Participation of MOH patients will be restricted to a maximum of 50%
of the total sample.
2.Prior use of Fremanezumab or another monoclonal antibody targeting
CGRP or CGRP receptor.
3.Prior use of less than two or more than four preventive drugs
according to the local national guidelines (34), with inadequate response
after sufficient doses and enough time or lack of tolerability.
4.Any medical condition that might prevent study completion or interfere
with interpretation of results.
5.History of any neurological or neurosurgical condition affecting the
brain.
6.History of moderate-severe head trauma.
7.History of other chronic pain syndrome with a frequency of five or
more days of pain per month.
8.Presence of daily headache
9.Pregnant or breastfeeding women.
10.Current or recent use of any other prophylactic treatment in the
preceding five half-lives prior to the start.
11.Exposure to onabotulinumtoxinA in the preceding four months.
12.Any expected surgery during the study.
13.Use of opioids or barbiturates.
14.Any condition contraindicating an MRI acquisition.
15.Completing headache diary at least 80% of the time during the
screening period.

Study & Design

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