An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Progressive Supranuclear Palsy (PSP)
About this trial
This is an interventional treatment trial for Progressive Supranuclear Palsy (PSP) focused on measuring Tauopathy, Steele-Richardson-Olszewski Syndrome, PSP
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
Sites / Locations
- Univ Alabama-Birmingham /ID# 165522
- Mayo Clinic Arizona /ID# 165521
- Cedars-Sinai Medical Center /ID# 165567
- Usc /Id# 165529
- University of California, Los Angeles /ID# 165669
- University of California, San /ID# 165560
- Univ California, San Francisco /ID# 165553
- Rocky Mountain Movement Disorders Center /ID# 165559
- UF Center for Movement Disorde /ID# 165561
- Mayo Clinic /ID# 165554
- University of South Florida /ID# 165556
- Augusta University Medical Center /ID# 165562
- Rush University Medical Center /ID# 165527
- University of Chicago Medical /ID# 165555
- Indiana University /ID# 165519
- University of Kentucky Chandler Medical Center /ID# 165566
- Mayo Clinic - Rochester /ID# 165518
- Cleveland Clinic Lou Ruvo Cent /ID# 165538
- Rutgers Robert Wood Johnson /ID# 165526
- Columbia Univ Medical Center /ID# 165528
- Cleveland Clinic Main Campus /ID# 165537
- Vanderbilt Univ Med Ctr /ID# 165520
- Kerwin Research Center /ID# 206872
- McGovern Medical School /ID# 165565
- Q-Pharm Pty Limited /ID# 165452
- Royal Adelaide Hospital /ID# 165451
- Alfred Hospital /ID# 165454
- University of Calgary /ID# 165667
- Toronto Western Hospital /ID# 165462
- Montreal Neurological Institut /ID# 165546
- CHUM - Notre-Dame Hospital /ID# 165461
- Policlinico Agostino Gemelli /ID# 165536
- University of Catanzaro /ID# 170214
- Istituto Neuro Mediterraneo IR /ID# 165533
- A.O. Santa Maria /ID# 165535
- IRCCS San Camillo /ID# 201229
- National Hospital Organization Higashinagoya National Hospital /ID# 208786
- National Hospital Organization Asahikawa Medical Center /ID# 208818
- National Hospital Organization Utano National Hospital /ID# 208780
- NHO Sendai Nishitaga National Hospital /ID# 209014
- Osaka University Hospital /ID# 208787
- National Center of Neurology and Psychiatry /ID# 208820
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg
M15-562 Placebo/M15-563 ABBV-8E12 2000 mg
M15-562 Placebo/M15-563 ABBV-8E12 4000 mg
Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).
Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.
Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.