Clinical trial NCT03391765: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Official title: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Progressive Supranuclear Palsy (PSP)
Keywords: Tauopathy
Steele-Richardson-Olszewski Syndrome
PSP
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-01-05
Enrollment: 142
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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). Those who completed the 52-week Treatment Period in Study M15-562 and met all entry criteria were eligible for enrollment into this study. This study planned for a Treatment Period of up to 5 years and a post-treatment follow-up visit approximately 20 weeks after the last dose of study drug (including participants who prematurely discontinued treatment). All participants received ABBV-8E12 as follows: those who received placebo in Study M15-562 were randomized, in a 1:1 ratio, to either 2000 or 4000 mg; those who received ABBV-8E12 at a dose of either 2000 or 4000 mg in Study M15-562 continued on the same dose in this study.

This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
timeFrame: Baseline, Week 52
measure: Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score
timeFrame: Baseline, Week 52
measure: Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score
timeFrame: Baseline, Week 52
measure: Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26
timeFrame: From Baseline to Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ Alabama-Birmingham /ID# 165522
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona /ID# 165521
state: Arizona
city: Beverly Hills
country: United States
facility: Cedars-Sinai Medical Center /ID# 165567
state: California
city: Los Angeles
country: United States
facility: Usc /Id# 165529
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 165669
state: California
city: San Diego
country: United States
facility: University of California, San /ID# 165560
state: California
city: San Francisco
country: United States
facility: Univ California, San Francisco /ID# 165553
state: California
city: Englewood
country: United States
facility: Rocky Mountain Movement Disorders Center /ID# 165559
state: Colorado
city: Gainesville
country: United States
facility: UF Center for Movement Disorde /ID# 165561
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic /ID# 165554
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 165556
state: Florida
city: Augusta
country: United States
facility: Augusta University Medical Center /ID# 165562
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center /ID# 165527
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical /ID# 165555
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University /ID# 165519
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center /ID# 165566
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 165518
state: Minnesota
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Cent /ID# 165538
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson /ID# 165526
state: New Jersey
city: New York
country: United States
facility: Columbia Univ Medical Center /ID# 165528
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 165537
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr /ID# 165520
state: Tennessee
city: Dallas
country: United States
facility: Kerwin Research Center /ID# 206872
state: Texas
city: Houston
country: United States
facility: McGovern Medical School /ID# 165565
state: Texas
city: Herston
country: Australia
facility: Q-Pharm Pty Limited /ID# 165452
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 165451
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Hospital /ID# 165454
state: Victoria
city: Calgary
country: Canada
facility: University of Calgary /ID# 165667
state: Alberta
city: Toronto
country: Canada
facility: Toronto Western Hospital /ID# 165462
state: Ontario
city: Montreal
country: Canada
facility: Montreal Neurological Institut /ID# 165546
state: Quebec
city: Montréal
country: Canada
facility: CHUM - Notre-Dame Hospital /ID# 165461
state: Quebec
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli /ID# 165536
state: Lazio
city: Catanzaro
country: Italy
facility: University of Catanzaro /ID# 170214
city: Pozzilli
country: Italy
facility: Istituto Neuro Mediterraneo IR /ID# 165533
city: Terni
country: Italy
facility: A.O. Santa Maria /ID# 165535
city: Venice
country: Italy
facility: IRCCS San Camillo /ID# 201229
city: Nagoya-shi
country: Japan
facility: National Hospital Organization Higashinagoya National Hospital /ID# 208786
state: Aichi
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center /ID# 208818
state: Hokkaido
city: Kyoto City
country: Japan
facility: National Hospital Organization Utano National Hospital /ID# 208780
state: Kyoto
city: Sendai
country: Japan
facility: NHO Sendai Nishitaga National Hospital /ID# 209014
state: Miyagi
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 208787
state: Osaka
city: Kodaira
country: Japan
facility: National Center of Neurology and Psychiatry /ID# 208820
state: Tokyo
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: