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

Phase 1

• Conditions: Prevention of chronic migraine; MedDRA version: 14.1Level: LLTClassification code 10027608Term: Migraine, unspecifiedSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001707-36-NO
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-29
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

- Adults = 18 to = 60 years of age upon entry into screening
- History of at least 5 attacks of migraine without aura and/or migraine with visual,
sensory, speech and/or language, retinal or brainstem aura according to the IHS Classification ICHD-III (Headache Classification Committee of the International
Headache Society, 2013) based on medical records and/or patient self-report
- History of = 15 headache days per month of which = 8 headache days were
assessed by the subject as migraine days per month in each of the 3 months
prior to screening

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 490
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
- Chronic migraine with continuous pain, in which the subject does not experience any pain free periods (of any duration) during the 1 month prior to screening
- Taken an opioid and/or opioid-containing analgesic for any indication on greater than 6 days during the 3 months prior to screening
- Taken a butalbital-containing analgesic for any indication on greater than 6 days during the 3 months prior to screening
- No therapeutic response in prophylaxis of migraine after an adequate therapeutic trial to > 3 of the medication categories (detailled in the protocol)
- Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase (Refer to Section 6.5 for the list
of excluded medications, devices and procedures)
- Changing the dose of a concomitant medication that is not prescribed for migraine prophylaxis but that may have migraine prophylaxis effects within 1 month prior to screening. (Refer to Section 6.4 and Section 6.5 for the list of these medications)
- Received botulinum toxin in the head and/or neck region within 4 months prior to Screening
- History or evidence of unstable or clinically significant medical condition including but not limited to the following:
· Currently diagnosed with fibromyalgia, and/or chronic pelvic pain
· History of major psychiatric disorder, or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 24 at screening.
· History of seizure disorder or other significant neurological conditions other than migraine
· Poorly controlled hypertension (systolic blood pressure [BP] 150 mm Hg and/or diastolic BP 90 mm Hg or greater)
· Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening
- Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with AMG 334 through 16 weeks after the last dose of investigational product.
- Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(-ies)

Study & Design

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