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

Phase 1

• Conditions: Prevention of chronic migraine; MedDRA version: 18.1Level: LLTClassification code 10027608Term: Migraine, unspecifiedSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001707-36-PL
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-11
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 651

Inclusion Criteria

- Adults = 18 to = 65 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 622
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 26

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 12 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 of the protocol 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 of the protocol 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 that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Excluded medical conditions include but not limited to:
· Currently diagnosed with fibromyalgia, and/or chronic pelvic pain
· History of major psychiatric disorder (such as schizophrenia or other psychotic disorders, bipolar disorder, obsessive-compulsive disorder,
post-traumatic stress 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 in the judgment of the investigator, or systolic blood pressure (BP) = 160 mm Hg or diastolic BP = 100 mm Hg as measured at the screening or week -4 study visits
· 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
investigational product 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), or previous discontinuation from another drug study due to a serious adverse event

Study & Design

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