Overview

This trial is active, not recruiting.

Condition treatment for prevention of chronic migraine
Treatment amg 334
Phase phase 2
Sponsor Amgen
Start date June 2014
End date March 2017
Trial size 612 participants
Trial identifier NCT02174861, 2013-005311-27, 20130255

Summary

To assess the long-term safety and efficacy of AMG 334 .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
AMG 334 Dose level 2
amg 334
All subjects will receive AMG 334 periodically for 13 months followed by a safety follow up visit .The subjects who complete the 12-week double-blind treatment phase of the AMG 334 20120295 parent study and meet all AMG 334 20130255 eligibility criteria will be enrolled into this study. Enrollment should occur within 14 days after the week 12 visit of the parent study.

Primary Outcomes

Measure
The safety and tolerability of long-term administration of AMG 334 will be measured by the number of participants with treatment-related AEs reported in the eCRFs.
time frame: 13 months -Completion of Open Label treatment
CHU Substudy: Number of participants able to administer a full dose of AMG 334 in home-use, using either two prefilled syringes (PFS) or two prefilled autoinjector/pens (AI/pen) as recorded on the IP Admin page of the eCRFs
time frame: 3 months out of the 13 months -Completion of Open Label treatment

Secondary Outcomes

Measure
Number of participants reporting monthly migraine days from baseline in eDiary
time frame: 13 months -Completion of Open Label treatment
Number of participants with at least a 50% reduction from baseline in monthly migraine days as reported in eDiary
time frame: 13 months -Completion of Open Label treatment
Number of participants with a change from baseline in monthly acute migraine-specific medication treatment days as reported in eDiary and Con-Med Page of eCRFs
time frame: 13 months -Completion of Open Label treatment
Number of participants with a change from baseline in monthly cumulative hours of headache as reported in eDiary and eCRFs
time frame: 13 months -Completion of Open Label treatment
CHU Substudy: the safety and tolerability of AMG 334 administered using two 1-mL PFS or two 1-mL AI/pens will be measured by the number of participants with device releated AE/ADEs reported on the eCRFs
time frame: 3 months out of the 13 months -Completion of Open Label treatment

Eligibility Criteria

Male or female participants from 18 years up to 66 years old.

Inclusion Criteria: 1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures 2. 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. 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. Systolic blood pressure (BP) 160 mm Hg and/or diastolic BP 100 mm Hg or greater at screening/Day 1. 3. Subject who used excluded concomitant medications between week 8 and week 12 of the parent study

Additional Information

Official title An Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 334
Description This is a multicenter, open-label study to assess the long-term safety and efficacy of AMG 334. All subjects will receive an open-label AMG 334 subcutaneous (SC) dose periodically for 13 months followed by a safety follow- up visit .
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Amgen.