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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
701 East Hampden Avenue
Englewood, Colorado 80113
Englewood, Colorado 80113
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials