Evaluation of Tolfenamic Acid in Individuals With PSP at 12-Weeks

Progressive Supranuclear Palsy Clinical Trial

Official title: A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Tolfenamic Acid for the Treatment of Progressive Supranuclear Palsy

Status Not yet recruiting

Clinical Trial Summary

This is a 12-week study of oral tolfenamic acid vs. placebo in Progressive Supranuclear Palsy (PSP)

Clinical Trial Description

This is a 12-week, Phase 2a randomized, double-blind, placebo-controlled, parallel group study evaluating the safety and efficacy of tolfenamic acid (50 mg, 300 mg, and 600 mg daily) compared with placebo administered to subjects with PSP. The study will include 8 visits and a final telephone contact: screening (Week -6: Visit 1), randomization (7 to 10 days prior to Week 0: visit 2), treatment (Week 0 through Week 12: Visits 2 - 6), end of study Week 12: Visit 7), and telephone contact (Visit 8). Lumbar puncture will be obtained from consenting subjects at screening (Week -6: visit 10 and End of Study (Week 12: Visit 7) to primary exploratory biomarkers. ;

Related Conditions & MeSH terms

• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

• NCT number: NCT04253132
• Study type: Interventional
• Source: NeuroTau, Inc.
• Contact: Zoltan Mari, MD
• Phone: 702 483-6000
• Email: mariz@ccf.org
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2021
• Completion date: December 31, 2022