A Study of the Effects of AMG 334 to Prevent Migraine Headaches

Phase 1

• Conditions: Migraine Prevention; MedDRA version: 18.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-004464-38-NL
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-30
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 852

Inclusion Criteria

Criteria to be assessed prior to entering the subject into the initial screening phase and/or baseline phase:
•Adults = 18 to = 65 years of age upon entry into screening
•History of migraine (with or without aura) for = 12 months prior to screening according to the IHS Classification ICHD-3 based on medical records and/or patient self-report
• Migraine frequency: = 4 and < 15 migraine days per month on average across the 3 months prior to screening
• Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening

Criteria to be assessed during the baseline phase and confirmed prior to randomizing the subject into the double-blind treatment phase:
• Migraine frequency: = 4 and < 15 migraine days during the baseline phase based on the eDiary calculations
• Headache frequency: < 15 headache days during the baseline phase based on the eDiary calculations
• Demonstrated at least 80% compliance with the eDiary
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 852
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Older than 50 years of age at migraine onset
• History of cluster headache or hemiplegic migraine headache
• Unable to differentiate migraine from other headaches
• No therapeutic response with > 2 of the following 7 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are:
- Category 1: Divalproex sodium, sodium valproate
- Category 2: Topiramate
- Category 3: Beta blockers
- Category 4: Tricyclic antidepressants
- Category 5: Serotonin-norepinephrine reuptake inhibitors
- Category 6: Flunarizine, verapamil
- Category 7: Lisinopril, candesartan
• Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase
• Received botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline phase or during the baseline phase
• Taken the following for any indication in any month during the 2 months prior to the start of the baseline phase:
- Ergotamines or triptans on = 10 days per month, or
- Simple analgesics (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on = 15 days per month, or
- Opioid- or butalbital-containing analgesics on = 4 days per month
• Anticipated to require any excluded medication, device, or procedure during the study
• Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain)
• History of major psychiatric disorder (such as schizophrenia and bipolar disorder), or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 19 at screening. Subjects with anxiety disorder and/or major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 3 months prior to the start of the baseline phase.
• History of seizure disorder or other significant neurological conditions other than migraine. Note: A single childhood febrile seizure is not exclusionary.
• Malignancy within the 5 years prior to screening, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
• Human immunodeficiency virus (HIV) infection by history
• Hepatic disease by history or total bilirubin = 2.0 x ULN or alanine transaminase (ALT) or aspartate aminotransferase (AST) = 3.0 x ULN, as assessed by the central laboratory at initial screening
• Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening
• History or evidence of any other unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Subject has any clinically significant vital sign, laboratory, or ECG abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation
• The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening
• Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical records, patient self-report, or positive urine

Study & Design

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