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

Phase 1

• Conditions: Prevention of chronic migraine; MedDRA version: 17.0Level: LLTClassification code 10027608Term: Migraine, unspecifiedSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-005311-27-NO
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-04
• Study Completion: 2017-05-26
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 609

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

- 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 with
the study evaluation, procedures or completion
- 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
- In the opinion of the investigator, subject demonstrated poorly controlled
hypertension following randomization into the parent study
- Systolic blood pressure (BP) 150 mm Hg and/or diastolic BP 90 mm Hg or
greater at screening/Day 1
- 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
- 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, hormonal birth control
methods (pills, shots/injections, implants or patches), intrauterine devices,
surgical contraceptive methods (vasectomy 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the safety and tolerability of long-term administration of AMG 334;Secondary Objective: To characterize the efficacy of long-term administration of AMG 334 as assessed by:<br>• Change from baseline in monthly migraine days<br>• Proportion of subjects with at least 50% reduction from baseline in monthly migraine<br>days<br>• Reduction from baseline in monthly migraine attacks in subjects with chronic<br>migraine;Primary end point(s): Subject incidence of adverse events.;Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol.<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Change in monthly migraine days from baseline at assessment timepoints<br>• At least a 50% reduction from baseline in monthly migraine days at assessment<br>timepoints<br>• Change in monthly migraine attacks from baseline at assessment timepoints;Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol.