Status:
TERMINATED
An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Lead Sponsor:
AbbVie
Conditions:
Progressive Supranuclear Palsy (PSP)
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to assess the long-term safety and efficacy of ABBV-8E12 (tilavonemab) in participants with progressive supranuclear palsy (PSP).
Detailed Description
This study (M15-563) was a Phase 2, randomized, double-blind, multiple-dose, multicenter, long-term extension of NCT 02985879 (Study M15-562) in participants with progressive supranuclear palsy (PSP)....
Eligibility Criteria
Inclusion
- Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)
- In the opinion of the investigator, the participant was compliant during participation in Study M15-562 (NCT02985879)
- Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)
Exclusion
- Participants who weigh less than 44 kg (97 lbs) at the time of study entry
- Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
- Participant has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results
- More than 8 weeks have elapsed since the participant received his/her last dose of study drug in Study M15-562 (NCT02985879)
- Participant is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the participant is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2019
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT03391765
Start Date
January 24 2018
End Date
December 13 2019
Last Update
February 3 2021
Active Locations (42)
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1
Univ Alabama-Birmingham /ID# 165522
Birmingham, Alabama, United States, 35294
2
Mayo Clinic Arizona /ID# 165521
Phoenix, Arizona, United States, 85054
3
Cedars-Sinai Medical Center /ID# 165567
Beverly Hills, California, United States, 90211
4
Usc /Id# 165529
Los Angeles, California, United States, 90033