NCT02985879
Brief summary
The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics of an active drug in subjects with progressive supranuclear palsy (PSP).
Interventional study
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Please note, participation in the clinical trial is open to patients with the disease or condition under investigation. |
Age:
40 Years and older.
Key Inclusion Criteria:
- Male or female participant with age 40 years or greater at the time of signed consent
- Meets the criteria for possible or probable progressive supranuclear palsy (PSP;
Steele-Richardson-Olszewski Syndrome)
- Presence of PSP symptoms for less than 5 years
- Participant is able to walk 5 steps with minimal assistance (stabilization of one arm
or use of cane/walker)
- Participant has an identified, reliable, study partner (e.g., caregiver, family
member, social worker, or friend)
Key Exclusion Criteria:
- Participants who weigh less than 44 kg (97 lbs) at screening
- Mini-Mental State Examination (MMSE) score less than 15 at screening
- Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
- Participant 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 participant has a history of or currently has schizophrenia, schizoaffective
disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental
Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10)
criteria
- Participant has had a significant illness or infection requiring medical intervention
in the past 30 days
