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Buntanetap for Early Parkinson's Disease
Phase 3
Waitlist Available
Research Sponsored by Annovis Bio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 2 months, 3 months and 6 months visits
Awards & highlights
Study Summary
This trial is testing a new drug for early Parkinson's disease to see if it is safe and effective. There will be 5 in-clinic visits and 7 phone calls over the course of 7-8 months.
Eligible Conditions
- Parkinson's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month, 2 months, 3 months and 6 months visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 2 months, 3 months and 6 months visits
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state)
Safety and tolerability
Secondary outcome measures
Change From Baseline to Month 6 in The Sum of MDS-UPDRS Total Score (OFF-state)
Change From Baseline to Month 6 on Change on Clinical Global Impression of Severity (CGIS) (OFF-state)
Change from Baseline to Month 6 in the MDS-UPDRS Part III (OFF-state)
+2 moreSide effects data
From 2022 Phase 1 & 2 trial • 75 Patients • NCT0452435110%
procedural headache
10%
paraesthesia
10%
back pain
10%
headache
10%
constipation
10%
post lumbar puncture syndrome
10%
erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Posiphen, 40mg (Parkinson's Participants)
Posiphen, 20mg (Parkinson's Participants)
Posiphen, 10mg (Parkinson's Participants)
Posiphen, 80mg (Parkinson's Participants)
Posiphen, 5mg (Parkinson's Participants)
Placebo (Parkinson's Participants)
Placebo (Alzheimer's Participants)
Posiphen, 80mg (Alzheimer's Participants)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 20 mg buntanetap/posiphenExperimental Treatment1 Intervention
Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Group II: 10 mg buntanetap/posiphenExperimental Treatment1 Intervention
Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months
Group III: PlaceboPlacebo Group1 Intervention
Placebo oral capsule with daily administration for a period of 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
buntanetap/posiphen
2022
Completed Phase 3
~530
Find a Location
Who is running the clinical trial?
TFS Trial Form SupportIndustry Sponsor
19 Previous Clinical Trials
1,377 Total Patients Enrolled
Annovis Bio Inc.Lead Sponsor
4 Previous Clinical Trials
418 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an intrauterine device (IUD).Both fallopian tubes are blocked.You are between 40 and 85 years old.Your memory and thinking skills are good, and you can take care of yourself without help from someone else.You are using an intrauterine hormone-releasing system.You have been diagnosed with Parkinson's disease according to specific clinical criteria.You have a history of severe mental disorders like schizophrenia, bipolar disorder, or major depression, as defined by the DSM. However, if you have mild depression and are on stable treatment with certain medications, you may still be eligible.It's okay if you have a history of seizures but only if you are taking medicine for it and your condition is stable.You have a history of heart rhythm problems or a long QT interval on an EKG test.Your heart beats too slowly or too quickly on the screening test.Your diabetes is not well controlled, or your HbA1c levels are higher than 7.5%.You need to score between 22-30 on a memory and thinking test and be able to live on your own without needing someone to help you.You are currently taking medications that affect the way your body processes other drugs.You have been diagnosed with Parkinson's disease based on specific medical criteria.Your score for how Parkinson's disease affects your movement is between 1 and 3 during the day, and you experience symptoms for less than 2 hours each day when your medication is not working.You are between 40 and 85 years old.You have not had thoughts of hurting yourself or tried to hurt yourself in the last month according to a specific assessment.You can still participate if you are taking standard medication for Parkinson's, epilepsy, mood stabilization, or neuropathic pain.You have a serious problem with your kidneys or liver.Your recent lab tests show significant problems with your liver or other important values. If your liver function tests are more than twice the normal limit, you cannot participate.You are at risk of hurting yourself or someone else, according to the doctors.You have had a serious problem with alcohol or drugs in the past 5 years.People who have trouble learning or have delays in their development.You have had cancer within the past year, except if you had treatment that could potentially cure it and there is no sign of it coming back. If you have stable untreated prostate cancer or skin cancers, you are not excluded.
Research Study Groups:
This trial has the following groups:- Group 1: 10 mg buntanetap/posiphen
- Group 2: 20 mg buntanetap/posiphen
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the mortality rates associated with Buntanetap use?
"Buntanetap's safety has been well studied in both preclinical and clinical settings, so it received a score of 3."
Answered by AI
Are patients who are 80 years or younger being accepted for this clinical trial?
"According to the listed eligibility requirements, people aged 40 to 85 are qualified to apply for this trial. In contrast, there are 29 trials geared towards people under 18 and 512 trials for those over 65."
Answered by AI
Are patient volunteers being accepted for this experiment right now?
"Yes, this trial is still recruiting according to the latest information available on clinicaltrials.gov. The study was originally posted on August 3rd, 2022 and has since been updated October 28th of the same year."
Answered by AI
What are investigators hoping to study and discover through this trial?
"The primary objective of this trial is to assess safety and tolerability through physical examinations, vital signs, clinical laboratory values, 12-lead ECG, use of concomitant medications, and AE reports. Secondary objectives include assessing the MDS-Unified Parkinson's disease Rating Scale Total Score, Change on Clinical Global Impression of Severity (OFF-state), and Percentage of Responders with "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (ON-state)."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Washington
What site did they apply to?
Inland Northwest Research
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