A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP).
Status: | Active, not recruiting |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 1/25/2019 |
Start Date: | December 12, 2016 |
End Date: | March 23, 2020 |
A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics
of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).
of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).
Inclusion Criteria:
- Male or female subject with age 40 years or greater at the time of signed consent.
- Meets the criteria for possible or probable progressive supranuclear palsy
(Steele-Richardson-Olszewski Syndrome).
- 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).
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.
We found this trial at
28
sites
701 East Hampden Avenue
Englewood, Colorado 80113
Englewood, Colorado 80113
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