Chronic migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Aimovig
Product Name: AMG 334 PFS
Product Code: AMG 334
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Not applicable
CAS Number: 1582205-90-0
Curre
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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 480 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 207
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of erenumab compared with placebo on achieving medication overuse headache (MOH) remission during the double-blind treatment period (DBTP);Secondary Objective: - To evaluate the effect of erenumab compared with placebo in reducing AHMD during the DBTP - To evaluate the effect of erenumab compared with placebo on sustaining MOH remission during the DBTP - To evaluate the effect of erenumab compared with placebo on reducing the impact of migraines on physical impairment and everyday activities as measured by the Migraine Physical Function Impact Diary (MPFID) during the DBTPa - • To evaluate the effect of erenumab compared to placebo on change from baseline in headache impact scores as measured by the Headache Impact Test (HIT-6)a;Primary end point(s): Absence of MOH at month 6 as defined by mean monthly acute headache medication days (AHMD) < 10 days over months 4, 5, and 6 (week 12 through 24) OR mean monthly headache days (MHD) < 14 days over months 4, 5, and 6 (week 12 through 24) of the DBTP where AHMD include any eDiary day in which an acute headache medication intake is reported;Timepoint(s) of evaluation of this end point: Months 4,5 and 6 (week 12 through 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in mean monthly AHMD over months 4, 5, and 6 (week 13 through 24) of the DBTP - Sustained MOH remission during DBTP, as defined by absence of MOH at months 3 (week 12) and 6 (week 24) of the DBTP, and "absence of MOH" is achieved when mean monthly AHMD < 10 days OR mean MHD < 14 days over the respective 3-month period - Change from baseline in mean monthly average physical impairment domain scores as measured by the MPFID over months 4, 5, and 6 (week 13 through 24) of the DBTP - Change from baseline in mean monthly average impact on everyday activities domain scores as measured by the MPFID over months 4, 5, and 6 (week 13 through 24) of the DBTP - Change from baseline in mean HIT-6 score over months 4, 5, and 6 (week 13 through 24) of the DBTP;Timepoint(s) of evaluation of this end point: Months 4,5 and 6 (week 12 through 24) | — |
Countries
Australia, Austria, Canada, Czechia, Czech Republic, Finland, France, Hungary, Italy, Japan, Poland, Portugal, Spain, United Kingdom, United States
Contacts
Public ContactMedical Information Department
Amgen Biofarmacêutica, Lda.
Outcome results
None listed