drugset / Trial / NCT05357989

A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD

NCT05357989 ↗

Phase 3 Completed 523 enrolled Annovis Bio Inc. TFS Trial Form Support · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD. Study details include: * The study duration will be up to 7-8 months. * The double-blind treatment duration will be up to 6 months. * There will be 5 in-clinic visits and 7 phone calls

Timeline

Start
2022-08-03
Primary completion
2023-12-04
Completion
2023-12-04

Outcome

Met primary endpoint

release “today announced new data from its Phase III PD study demonstrating that buntanetap is safe and effective in improving motor and non-motor activities” annovisbio.com ↗

release “Buntanetap’s activity resulted in statistically significant improvements in all primary and secondary endpoints in the specified populations as well as in cognition.” annovisbio.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject buntanetap Small molecule 10 mg Oral
Subject buntanetap Small molecule 20 mg Oral

Indications