NCT04937530

RT001 in Patients With Progressive Supranuclear Palsy (PSP) PROGRESSIVE SUPRANUCLEAR PALSY

A Randomized, Double-blind, Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Progressive Supranuclear Palsy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Biojiva LLC · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled trial of RT001 in patients with PSP.

Detailed description

This is a randomized, placebo-controlled trial of RT001 in patients with PSP to assess the efficacy, safety and tolerability of RT001. Subjects will be randomized to RT001 or placebo and will receive study drug for 48 weeks.

Conditions

• Progressive Supranuclear Palsy

Interventions

Type	Name	Description
DRUG	RT001	RT001 8.64 g/d (3 capsules TID) for 1 month followed by 5.76 g/d (3 capsules BID) for an additional 11 months
DRUG	Placebo	Placebo Comparator: Placebo Inactive comparator capsule 960 mg/capsule: 3 capsules TID for 4 weeks, followed by 3 capsules BID for the remaining 44 weeks.

Timeline

• Start date: 2021-06-23
• Primary completion: 2022-07-30
• Completion: 2022-08-30
• First posted: 2021-06-24
• Last updated: 2021-06-25

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study