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

Phase 1

• Conditions: Prevention of episodic migraine; MedDRA version: 20.0Level: LLTClassification code 10027608Term: Migraine, unspecifiedSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-005331-90-DK
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-17
• Study Completion: 2019-11-12
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 483

Inclusion Criteria

- Adults = 18 to = 60 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-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report - Migraine frequency: = 4 and = 14 migraine days per month in each of the 3 months prior to screening - Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month (with = 50% of the headache days being migraine days) 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 468
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
- No therapeutic response with > 2 of the eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial ( refer to criterion 4.2.5 in the protocol) - Used a prohibited medication, device or procedure prior to the start of the baseline phase (Refer to Section 6.4 of the protocol for the list of these excluded treatments and the timeframes prior to the start of the baseline phase)
- Received botulinum toxin in the head and/or neck region within 6 months prior to the start of the baseline phase
- Taken the following for any indication in any month during the 3 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 = 3 days per month - History or evidence of unstable or clinically significant medical condition including but not limited to the following:
• Chronic pain syndromes (eg, fibromyalgia, chronic back pain, 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.
- Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product through 12 weeks after the last dose of investigational product if receiving AMG 334 70 mg, and 16 weeks after the last dose of investigational product if receiving AMG 334 140 mg.
- Currently receiving treatment in another investigational device or drug study, or less than 90 days prior to screening 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