Summary

Eligibility
for people ages 41-86 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a Phase 2a study to assess the safety and tolerability of TPN-101 patients with PSP.

Details

This is a Phase 2a multi-center, randomized, double-blind, placebo-controlled parallel-group, 4-arm study with an open-label treatment phase in patients with PSP. This study includes a 6-week Screening Period, a 24-week Double-blind Treatment Period, a 24-week Open label Treatment Period, and a Follow-up Visit 4 weeks post treatment.

Keywords

Progressive Supranuclear Palsy Supranuclear Palsy, Progressive TPN-101, 100 mg/day TPN-101, 200 mg/day TPN-101, 400 mg/day

Eligibility

You can join if…

Open to people ages 41-86

  1. Clinical diagnosis of probable progressive supranuclear palsy (PSP)
  2. Presence of PSP symptoms for less than 5 years
  3. Has a reliable caregiver/informant to accompany the patient to all study visits.
  4. Score ≥ 18 on the Mini Mental State Exam (MMSE) at Screening
  5. Patient must reside outside a skilled nursing facility or dementia care facility at the time of Screening, and admission to such a facility must not be planned. Residence in an assisted living facility is allowed

You CAN'T join if...

Patients must not meet any of the following criteria:

  1. Presence of other significant neurological or psychiatric disorders
  2. History of clinically significant brain abnormality
  3. Presence of cerebellar ataxia, choreoathetosis, early symptomatic autonomic dysfunction, or moderate to severe resting tremor, responsive to levodopa
  4. Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean
  5. Known presence of disease-associated mutation in TARDBP, GRN, CHMPB2, or VCP genes; or any other frontotemporal lobar degeneration causative genes not associated with underlying tau pathology
  6. History of clinically significant hematological, endocrine, cardiovascular, renal, hepatic, or gastrointestinal disease

Locations

  • UCSF Neurosciences Clinical Research Unit (NCRU)
    San Francisco California 94158 United States
  • Cleveland Clinic Lou Ruvo Center for Brain Health
    Las Vegas Nevada 89106 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Transposon Therapeutics, Inc.
ID
NCT04993768
Phase
Phase 2 Progressive Supranuclear Palsy Research Study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated