Phase 3
N=523
A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD
Parkinson's Disease, Idiopathic
Bottom Line
View on ClinicalTrials.gov: NCT05357989 ↗Enrolled (actual)
523
Serious AEs
3.8%
Results posted
Mar 2025
Primary outcome: Primary: Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state) — -0.10; 0.57; -0.04 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- buntanetap/posiphen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Annovis Bio Inc.
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state) |
-0.10; 0.57; -0.04 | — |
| SECONDARY Change From Baseline to Month 6 in the MDS-UPDRS Part III (OFF-state) |
-2.90; -1.04; -2.66 | — |
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
Eligibility Criteria
Inclusion Criteria
- Diagnosis of idiopathic Parkinson Disease according to MDS Clinical Diagnostic Criteria for Parkinson's Disease.
- H&Y score =1, 2 or 3 during ON-state & OFF-state 100 bpm) on the ECG at screening.
- Has uncontrolled Type-1 or Type-2 diabetes. A subject with HbA1c levels up to 7.5% can be enrolled if the investigator believes the subject's diabetes is under control.
- Has clinically significant renal or hepatic impairment.
- Has any clinically significant abnormal laboratory values. Subjects with liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than twice the upper limit of normal will be excluded.
- Is at imminent risk of self-harm, based on clinical interview and responses on the C SSRS, or of harm to others in the opinion of the Investigators. Subjects must be excluded if they report suicidal ideation with intent, with or without a plan or method (e. g. positive response to Items 4 or 5 in assessment of suicidal ideation on the C SSRS) in the past 2 months, or suicidal behavior in the past 6 months.
- Has cancer or has had a malignant tumor within the past year, except subjects who underwent potentially curative therapy with no evidence of recurrence. (Subjects with stable untreated prostate cancer or skin cancers are not excluded).
- Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version DSM.
- Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 60 days prior to the start of screening. The end of a previous investigational trial is the date the last dose of an investigational agent was taken, or five half-lives of the investigational drug, whichever is greater.
- Subjects with learning disability or developmental delay.
- Subjects whom the site PI deems to be otherwise ineligible.
- Subjects with a known allergy to the investigational drug or any of its components.
- Subject is currently pregnant, breast-feeding and/or lactating.
- Subject is currently taking CYP3A4 inhibitors and/or inducers.
Data sourced from ClinicalTrials.gov (NCT05357989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.