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This is a 12-week study of oral tolfenamic acid vs. placebo in Progressive Supranuclear Palsy (PSP)
Full 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.
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Inclusion criteria
Subjects may be included in the study only if they meet all of the following criteria:
Exclusion criteria
Subjects will be excluded from the study for any of the following reasons:
Primary purpose
Allocation
Interventional model
Masking
24 participants in 6 patient groups, including a placebo group
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Central trial contact
Zoltan Mari, MD
Data sourced from clinicaltrials.gov
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