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-FI
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-02
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

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

Inclusion Criteria

101 Subject has provided informed consent prior to initiation of any study-specific activities/procedures
102 Age = 18 years on entry into the study
103 Documented history of migraine without aura and/or migraine with aura according to the ICHD-3 Classification for = 12 months at screening
104 Documented history of CM for a minimal duration of 6 months before screening
105 Current diagnosis of MOH
106 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
107. = 14 headache days during the 28-day baseline period out of which = 8 headache days meet criteria as migraine days
108 Observation of acute migraine medication overuse during baseline. Medication overuse at baseline is defined as:
- = 10 days of combination treatment OR
- = 10 days of short-acting opioids/opioid-containing medication OR
- = 10 days of triptans, ergots, OR
- = 15 days of NSAIDs or simple analgesics intake
110 At least 2 acute headache medication days per week for each week with at least 5 diary days
111 Demonstrated at least 80% compliance with the eDiary (eg, must complete eDiary items on at least 23 out of 28 days during the baseline phase)
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 653
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

201 Age > 50 years at migraine onset or > 65 years at CM onset
202 History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
203 Current concomitant diagnosis of a secondary type of headache other than MOH
204 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
205 Chronic headache with continuous pain, in which the subject does not
experience headache-free periods of any duration
206 No therapeutic response in prevention of migraine after an adequate therapeutic trial of > 3 of the following medication categories. These medication categories include:
- Category 1: Topiramate
- Category 2: Other antiepileptics (eg, divalproex sodium, sodium
valproate, carbamazepine)
- Category 3: Beta blockers
- Category 4: Tricyclic antidepressants
- Category 5: Serotonin-norepinephrine reuptake inhibitors, selective
serotonin-reuptake inhibitors and other antidepressants
- Category 6: Calcium channel blockers (eg, verapamil, amlodipine) or
calcium antagonists (eg, flunarizine)
- Category 7: Angiotensin receptor blockers (eg, candesartan) or
angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril)
- Category 8: Botulinum toxin
- Category 9: Other centrally acting drugs used for migraine prophylaxis
(eg, pizotifen)
235. Changes in drug regimen (ie, changes in dose or frequency of use) of an allowed migraine preventive medication within 2 months prior to start of baseline
208 Received botulinum toxin in the head and/or neck region within 4 months prior to screening
236. Documented history of treatment with an anti-CGRP preventive treatment
210 Anticipated to require any excluded medication/device or procedure during the study
211 Subject likely to not be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the subject’s and investigator's knowledge
212 History or evidence of unstable or clinically significant medical condition that, in the opinion of the investigator or Amgen's physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or
completion.

Study & Design

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