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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
Pivotal Trial
Summary
This trial is testing a new pill called buntanetap/posiphen to help people with early Parkinson's Disease. The pill aims to reduce brain inflammation and protect nerve cells, which could improve movement and daily activities. The study will compare the effects of the pill over several 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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state)
Safety and tolerability
Secondary study objectives
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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: 20 mg buntanetap/posiphen
- Group 2: 10 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.
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