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

Phase 1

• Conditions: Prevention of chronic migraine; MedDRA version: 17.1Level: LLTClassification code 10027608Term: Migraine, unspecifiedSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-005311-27-CZ
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-15
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

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

Inclusion Criteria

Completed the 12-week study visit and did not end IP early during the double-blind treatment period of the AMG 334 20120295 parent study, and is appropriate for continued treatment

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 224

Exclusion Criteria

1. Development of any unstable or clinically significant medical
condition, laboratory or ECG abnormality following randomization into
the parent study, that in the
opinion of the investigator, would pose a risk to subject safety or
interfere withthe study evaluation, procedures or completion
2. Any subject who experienced an SAE in the parent study (AMG 334
20120295) for whom the investigator determined that there was a
reasonable possibility that the event may have been caused by
investigational medicinal product
3. In the opinion of the investigator, subject demonstrated poorly
controlled hypertension following randomization into the parent study
4. Systolic blood pressure (BP) 150 mm Hg and/or diastolic BP 90 mm
Hg or greater at screening/Day 1
5. Pregnant (as confirmed by the Week 12 urine pregnancy test of parent
study) or breastfeeding, or is a female expecting to conceive during the
study, including through 16 weeks after the last dose of investigational
product
6. 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.
Acceptable methods of effective birth control include not having
intercourse (true abstinence, when this is in line with the preferred and
usual lifestyle of the subject), hormonal birth control methods (pills,
shots/injections, implants or patches), intrauterine devices, surgical
contraceptive methods (vasectomy with medical assessment of the
surgical success of this procedure or bilateral tubal ligation), or two
barrier methods (each partner must use one barrier method) with
spermicide
- males must use a condom with spermicide; females must choose either
a Diaphragm with spermicide, OR Cervical cap with spermicide, OR
Contraceptive sponge with spermicide
- refer to the protocol for a definition of female subjects not of
childbearing potential

Study & Design

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