A Study to Evaluate the Efficacy, Safety , Tolerability and Pharmacokinetics of ABBV-8E12 in Subjects with Progressive Supranuclear Palsy.

Phase 1

• Conditions: Progressive Supranuclear Palsy; MedDRA version: 20.0Level: PTClassification code 10036813Term: Progressive supranuclear palsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-001635-12-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Male or female subject with age 40 years or greater at the time of signed consent.
• Meets the following criteria for possible or probable progressive supranuclear palsy (Steele-Richardson-Olszewski Syndrome)
- gradually progressive disorder, with age at disease onset greater than or equal to 40 years
- either or both of the following two items are met:
1. vertical supranuclear gaze palsy
2. slowing of vertical saccades AND postural instability with falls within the first 3 years of PSP symptoms
• Presence of PSP symptoms for less than 5 years.
• Subject is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker).
• 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

Exclusion Criteria

• Subjects who weigh less than 44 kg (97 lbs) at screening.
• MMSE score less than 15 at screening
• Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
• Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period.
• Evidence of any clinically significant neurological disorder other than PSP
• The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria.
• Subject has had a significant illness or infection requiring medical intervention in the past 30 days.

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 efficacy of ABBV-8E12 in slowing disease progression in subjects with progressive supranuclear palsy as measured by the PSP Rating Scale (PSP-RS).<br>- To assess the long term safety and tolerability of ABBV-8E12 for up to 52 weeks in subjects with progressive supranuclear palsy.;Secondary Objective: - To assess the pharmacokinetics of ABBV-8E12 in subjects with PSP. <br>- To assess the efficacy of ABBV-8E12 in slowing disease progression and functional impairment in subjects with PSP as measured by secondary endpoints.<br>- To assess the efficacy of ABBV-8E12 in slowing regional and/or whole brain atrophy in subjects with PSP as measured by volumetric MRI.;Primary end point(s): The change from baseline to Week 52 on the PSP-RS total score.;Timepoint(s) of evaluation of this end point: Weeks 12, 24, 36 and 52