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

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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).


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
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Beverly Hills, California 90211
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Augusta, GA
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Birmingham, Alabama 35233
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1653 West Congress Parkway
Chicago, Illinois 60612
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Chicago, Illinois 60637
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9500 Euclid Avenue
Cleveland, Ohio 44195
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Cleveland, OH
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Dallas, TX
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701 East Hampden Avenue
Englewood, Colorado 80113
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Englewood, CO
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1600 Southwest Archer Road
Gainesville, Florida 32610
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Gainesville, FL
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Houston, TX
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Jacksonville, Florida 32224
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Jacksonville, FL
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Kansas City, Missouri 64111
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Kansas City, MO
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La Jolla, California 92037
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La Jolla, CA
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Las Vegas, NV
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Lexington, KY
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Los Angeles, California 90033
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1215 21st Avenue South
Nashville, Tennessee 37232
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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New York, NY
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Portland, OR
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Rochester, Minnesota 55905
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Rochester, MN
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Round Rock, TX
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San Francisco, California 94143
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Scottsdale, Arizona 85259
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4202 East Fowler Avenue
Tampa, Florida 33612
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Westmead, New South Wales
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Westmead,
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