An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
- Conditions
- Progressive Supranuclear Palsy (PSP)MedDRA version: 20.0Level: PTClassification code 10036813Term: Progressive supranuclear palsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-001590-16-DE
- Lead Sponsor
- AbbVie Deutschland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
1. Subject completed the 52-week treatment period of Study M15-562.
2. In the opinion of the Investigator, subject was compliant during participation in Study M15-562.
3. Subject has an identified, reliable study partner (e.g., caregiver, family member, social worker, or friend).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 238
1. Subject weighs less than 44 kg (97 lbs.) at time of study entry.
2. Subject has any contraindication or inability to tolerate brain MRI.
3. 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.
4. More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562.
5. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To assess the long-term safety and tolerability of ABBV-8E12 in subjects with PSP.<br>• To assess the long-term efficacy of ABBV-8E12 in slowing disease progression.;Secondary Objective: • To assess the long-term efficacy of ABBV-8E12 in slowing disease progression and functional impairment.<br>• To assess the pharmacokinetics of ABBV-8E12.<br>• To assess the long-term efficacy of ABBV-8E12 in slowing regional and/or whole brain atrophy.;Primary end point(s): Change in Progressive Supranuclear Palsy Rating Scale (PSPRS).;Timepoint(s) of evaluation of this end point: Baseline up to 5 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living);Timepoint(s) of evaluation of this end point: Up to 5 years