TPN-101 for Progressive Supranuclear Palsy

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Transposon Therapeutics, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, TPN-101, to see if it is safe and can be tolerated by patients with Progressive Supranuclear Palsy (PSP). PSP is a rare brain disorder that affects movement and balance. The study will check if TPN-101 can help with symptoms or slow down the disease.

Eligibility Criteria

This trial is for patients with Progressive Supranuclear Palsy (PSP) who've had symptoms for less than 5 years and have a probable PSP diagnosis. Participants need to score at least 18 on the Mini Mental State Exam, live outside of nursing facilities, and have a reliable caregiver. It's not for those with certain genetic mutations or significant neurological, psychiatric, or other serious health issues.

Inclusion Criteria

You have been experiencing symptoms of PSP for less than 5 years.

Has a reliable caregiver/informant to accompany the patient to all study visits

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

See 3 more

Exclusion Criteria

Your progranulin level in your blood is significantly lower than normal.

You have specific genetic mutations known to cause frontotemporal lobar degeneration, except those related to tau pathology.

You have other important brain or mental health conditions.

See 3 more

Treatment Details

Interventions

Placebo (Drug)
TPN-101 (Other)

Trial OverviewThe study tests the safety and tolerability of TPN-101 at different doses (100 mg/day, 200 mg/day, and 400 mg/day) compared to a placebo in people with PSP. The goal is to find out how well patients handle the medication.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: TPN-101, Dose CExperimental Treatment1 Intervention

Group II: TPN-101, Dose BExperimental Treatment1 Intervention

Group III: TPN-101, Dose AExperimental Treatment1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention