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

Phase 1

• Conditions: Prevention of chronic migraine; MedDRA version: 19.1Level: LLTClassification code 10027608Term: Migraine, unspecifiedSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-14
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

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

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 651
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 with the 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 lst 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

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 days<br>• Change from baseline in monthly acute migraine-specific medication treatment days<br>• Change from baseline in monthly cumulative hours of headache<br>• Secondary Objective of CHU Substudy: To assess the safety and tolerability of AMG 334 administered using two 1-mL PFS or two 1-mL AI/pens;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 from baseline in monthly migraine days from baseline at assessment timepoints<br>• Achievement of at least a 50% reduction from baseline in monthly migraine days at assessment timepoints<br>• Change from baseline in monthly acute migraine-specific medication treatment days at assessment timepoints<br>• Change from baseline in cumulative monthly headache hours at assessment timepoints<br>CHU Substudy<br>• Subject incidence of adverse events, serious adverse events,<br>and adverse device effects;Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol.