Progressive Supranuclear Palsy (PSP)
Conditions
Interventions
investigational material(s)
Generic name etc : ABBV-8E12
INN of investigational material : -
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for
Sponsors
AbbVie G.K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject completed the 52-week treatment period in Study M15-562. - In the opinion of the investigator, the subject was compliant during participation in Study M15-562. - Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).
Exclusion criteria
Exclusion criteria: - Subjects 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). - Subject 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 subject received his/her last dose of study drug in Study M15-562. - Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years [ Time Frame: Up to approximately 5 years ] The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline). | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 (Activities of Daily Living) [ Time Frame: Up to approximately 5 years ] The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. - Change in Clinical Global Impression of Change (CGI-C) [ Time Frame: Up to approximately 5 years ] The CGI-C is a clinician's rating of change in disease severity. - Change in Schwab and England Activities of Daily Living Scale (SEADL) [ Time Frame: Up to approximately 5 years ] The SEADL assesses the subject's ability to perform daily activities. | — |
Countries
Europe, Japan, North America, Oceania
Outcome results
None listed