Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-01 @ 7:44 PM
Study NCT ID:
NCT04253132
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2019-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Tolfenamic Acid in Individuals With PSP at 12-Weeks
Sponsor:
NeuroTau, Inc.
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 12-week study of oral tolfenamic acid vs. placebo in Progressive Supranuclear Palsy (PSP)
Detailed 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: