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

Phase 1

• Conditions: Migraine Prevention; MedDRA version: 18.1Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-004463-20-PT
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-29
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 540

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
• Provided informed consent prior to initiation of any study-specific activities/procedures
• History of migraine (with or without aura) for = 12 months prior to screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) 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 (for example, completing eDiary items for 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 540
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 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)
• Concomitant use of 2 or more medications with possible migraine
prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase
• 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 (with BDI-II = 19) 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 upper limit of normal (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) asses

Study & Design

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