Buntanetap for Parkinson Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Medical University of South Carolina (MUSC) - The Murray Center for Research on Parkinson's Disease and Related Disorders, Charleston, SC
Parkinson Disease+1 More
Buntanetap - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to measure safety and efficacy of buntanetap 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

Eligible Conditions

  • Parkinson Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: Baseline, 1 month, 2 months, 3 months, and 6 months visits

Month 6
Change on Clinical Global Impression of Severity (CGIS) (OFF-state)
Month 6
MDS-Unified Parkinson's Disease Rating Scale Total Score
MDS-Unified Parkinson's Disease Rating Scale Total Score (OFF-state)
Percentage of Responders with "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (ON-state)
Percentage of Responders with "minimally improved," "much improved" or "very much improved" on participant global impression of change
Month 6
MDS-Unified Parkinson's Disease Rating Scale Part II+III
MDS-Unified Parkinson's Disease Rating Scale Part II+III (OFF-state)
Month 8
Safety and tolerability as accessed physical examinations, vital signs, clinical laboratory values, 12-lead ECG, use of concomitant medications, and adverse event (AE) reports
Month 8
Safety and tolerability as accessed by physical examinations, vital signs, clinical laboratory test results, electrocardiogram findings, adverse events (AEs) leading to study discontinuation, drug related AEs, severity of AEs and AEs.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

10 mg Buntanetap,
1 of 3
20 mg Buntanetap
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

450 Total Participants · 3 Treatment Groups

Primary Treatment: Buntanetap · Has Placebo Group · Phase 3

10 mg Buntanetap,
Drug
Experimental Group · 1 Intervention: Buntanetap · Intervention Types: Drug
20 mg Buntanetap
Drug
Experimental Group · 1 Intervention: Buntanetap · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 month, 2 months, 3 months, and 6 months visits
Closest Location: Medical University of South Carolina (MUSC) - The Murray Center for Research on Parkinson's Disease and Related Disorders · Charleston, SC
Photo of Charleston 1Photo of Charleston 2Photo of Charleston 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Parkinson Disease
0 CompletedClinical Trials

Who is running the clinical trial?

TFS Trial Form SupportIndustry Sponsor
19 Previous Clinical Trials
1,374 Total Patients Enrolled
3 Trials studying Parkinson Disease
39 Patients Enrolled for Parkinson Disease
Annovis Bio Inc.Lead Sponsor
3 Previous Clinical Trials
99 Total Patients Enrolled
1 Trials studying Parkinson Disease
75 Patients Enrolled for Parkinson Disease

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The IUS is a hormonal device that releases hormones into the uterus to stimulate the lining of the uterus.
You have no more than 2 hours of ON-state per day.
You are using oral, intravaginal, or transdermal combined hormonal contraception associated with inhibition of ovulation.
You are using oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.