NCT04993768

A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Transposon Therapeutics, Inc. · Industry
• Sex: All
• Age: 41 Years – 86 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Progressive Supranuclear Palsy

Interventions

Type	Name	Description
DRUG	TPN-101, 100 mg/day	100 mg/day of study investigational drug TPN-101 once daily for 24 weeks (double-blind treatment) followed by 400 mg/day TPN-101 for 24 weeks (open-label treatment).
DRUG	TPN-101, 200 mg/day	200 mg/day of study investigational drug TPN-101 once daily for 24 weeks (double-blind treatment) followed by 400 mg/day TPN-101 for 24 weeks (open-label treatment).
DRUG	TPN-101, 400 mg/day	400 mg/day of study investigational drug TPN-101 once daily for 24 weeks (double-blind treatment) followed by 400 mg/day TPN-101 for 24 weeks (open-label treatment).
DRUG	Placebo	Placebo once daily for 24 weeks (double-blind treatment) followed by 400 mg/day TPN-101 for 24 weeks (open-label treatment).

Timeline

• Start date: 2021-12-12
• Primary completion: 2024-02-24
• Completion: 2024-03-24
• First posted: 2021-08-06
• Last updated: 2026-04-08

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study