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

• Register: EUCTR
• Last refreshed on: 10 July 2017
• Main ID: EUCTR2013-005311-27-FI
• Date of registration: 14/01/2015
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: A Study of the Effects of AMG 334 to Prevent Migraine Headaches
• Scientific title: An Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 334
• Date of first enrolment: 18/03/2015
• Target sample size: 651
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005311-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Czech Republic, Denmark, Finland, Germany, Norway, Poland, Sweden, United Kingdom, United States

Contacts

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

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




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Prevention of chronic migraine
MedDRA version: 19.1 Level: LLT Classification code 10027608 Term: Migraine, unspecified System Organ Class: 100000004852

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: AMG 334
Product Code: AMG 334
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 334
Other descriptive name: AMG 334
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol.

Main Objective: To characterize the safety and tolerability of long-term administration of AMG 334

Primary end point(s): Subject incidence of adverse events.

Secondary Objective: To characterize the efficacy of long-term administration of AMG 334 as assessed by:
• Change from baseline in monthly migraine days
• Proportion of subjects with at least 50% reduction from baseline in monthly migraine days
• Change from baseline in monthly acute migraine-specific medication treatment days
• Change from baseline in monthly cumulative hours of headache
• 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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol.

Secondary end point(s): • Change from baseline in monthly migraine days from baseline at assessment timepoints
• Achievement of at least a 50% reduction from baseline in monthly migraine days at assessment timepoints
• Change from baseline in monthly acute migraine-specific medication treatment days at assessment timepoints
• Change from baseline in cumulative monthly headache hours at assessment timepoints
CHU Substudy
• Subject incidence of adverse events, serious adverse events,
and adverse device effects

Secondary ID(s)

2013-005311-27-SE

20130255

Source(s) of Monetary Support

Amgen Inc