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

NCT05357989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 523

Last updated 2025-03-03

Study results available
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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

Conditions

  • Parkinson's Disease, Idiopathic

Interventions

DRUG

buntanetap/posiphen

HPMC (vegetarian source) capsule shells

DRUG

Placebo

HPMC (vegetarian source) capsule shells

Sponsors & Collaborators

  • TFS Trial Form Support

    collaborator INDUSTRY

  • Annovis Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2023-12-04
Completion
2023-12-04
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Hungary
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357989 on ClinicalTrials.gov