A Phase 4 Randomized Controlled Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache

Phase 1

• Conditions: Chronic 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: EUCTR2018-003342-16-IT
• Lead Sponsor: AMGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 687

Inclusion Criteria

- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- Age > = 18 years on entry into the study
- Documented history of migraine without aura and/or migraine with aura according to the ICHD-3 Classification for > = 12 months at screening
- Documented history of CM for a minimal duration of 6 months before screening
- Current diagnosis of MOH
- History of treatment failure with at least 1 preventive treatment as defined as treatment discontinuation due to lack of efficacy, adverse event or general poor tolerability

*Please, refers to protocol for the full list.
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 687
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Age > 50 years at migraine onset or > 65 years at CM onset
- History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
- Current concomitant diagnosis of a secondary type of headache other than MOH
- History of clinically significant orofacial pain (eg, painful cranial neuropathies, temporomandibular disorder) that in the opinion of the investigator or Amgen's physician, if consulted, could interfere with the study evaluation, procedures or completion
- Chronic headache with continuous pain, in which the subject does not experience headache-free periods of any duration

*Please, refers to protocol for the full list.

Study & Design

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