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New treatment option for Parkinson's Disease (PD)
Official title A Study of Buntanetap in Participants With PD
ClinicalTrials.gov ID: NCT07284784
What this study is testing
What is buntanetap/posiphen?
buntanetap/posiphen is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for parkinson's disease (pd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- Diagnosis of idiopathic PD according to MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015) and a. Cohort 1: Participated...
- Have a support person who will accompany the participant on study visits at designated times.
- Female participants of childbearing potential\ must have a negative urine pregnancy test at screening, must be non-lactating, and must agree to use a...
- Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation,
- Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation,
You likely can't join if
- Cohort 1 only: Is currently receiving DBS treatment. (Participant may enroll in Cohort 2 if they meet the corresponding inclusion/exclusion criteria).
- A history of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version...
- A history of seizure disorder. If stable on medication, it is acceptable. Refer to Concomitant Medications section above for details on prohibited...
- A history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 450 ms for men and ≥ 460 ms for women, or...
- Bradycardia (\ 100 bpm) on the ECG at screening and deemed medically significant by the PI. Protocol ANVS-25002 Ver. 2.1; 09-23-2025 Confidential...
- Uncontrolled Type-1 or Type-2 diabetes. A participant with hemoglobin subunit alpha 1c (HbA1c) levels up to 7.5% can be enrolled if the investigator...
See the full eligibility criteria
Who can join
- Diagnosis of idiopathic PD according to MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015) and a. Cohort 1: Participated in a prior PD clinical trial with buntanetap. i. A legally authorized...
- Have a support person who will accompany the participant on study visits at designated times.
- Female participants of childbearing potential\ must have a negative urine pregnancy test at screening, must be non-lactating, and must agree to use a highly effective method of contraception (i.e., a method resulting in...
- Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation,
- Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation,
- Intrauterine device (IUD),
- Intrauterine hormone-releasing system (IUS),
- Bilateral tubal occlusion,
- Vasectomized partner (a vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the participant, and the absence of sperm has been confirmed. If not...
- Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The...
- Non-childbearing potential includes surgically sterilized or postmenopausal with no menstrual bleeding for at least one year prior to study start. Protocol ANVS-25002 Ver. 2.1; 09-23-2025 Confidential Page 30 of 54
- Male participants must be sterile or sexually inactive or agree not to father a child during the study and one month after the last dose of study medication and must agree to use a barrier method for contraception...
- Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation,
- Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation,
- IUD,
- IUS,
- Bilateral tubal occlusion.
- No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the C-SSRS.
- Stability of permitted medications for at least 4 weeks prior to screening. Refer to Concomitant Medications section above for details on prohibited and permitted medications.
- Standard of care anti-parkinsonian medication,
- Cholinesterase inhibitors and/or memantine medication,
- Anticonvulsant medications used for epilepsy or mood stabilization, or neuropathic pain indications, and have not had a breakthrough seizure 3 years prior to screening,
- Mood-stabilizing psychotropic agents including, but not limited to, lithium,
- Adequate visual and hearing ability (physical ability to perform all the study assessments).
- Good general health with no disease expected to interfere with the study.
What rules you out
- Cohort 1 only: Is currently receiving DBS treatment. (Participant may enroll in Cohort 2 if they meet the corresponding inclusion/exclusion criteria).
- A history of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM)...
- A history of seizure disorder. If stable on medication, it is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications.
- A history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 450 ms for men and ≥ 460 ms for women, or torsades de pointes.
- Bradycardia (\ 100 bpm) on the ECG at screening and deemed medically significant by the PI. Protocol ANVS-25002 Ver. 2.1; 09-23-2025 Confidential Page 31 of 54
- Uncontrolled Type-1 or Type-2 diabetes. A participant with hemoglobin subunit alpha 1c (HbA1c) levels up to 7.5% can be enrolled if the investigator believes the participant's diabetes is under control.
- Clinically significant renal (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] \ 2.0X the upper limit of normal [ULN] and/or total bilirubin \> 2.0X ULN).
- Any clinically significant abnormal laboratory values. Participants with liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than twice ULN 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. Participants must be excluded if they report suicidal ideation with...
- Cancer or has had a malignant tumor within the past year, except participants who underwent potentially curative therapy with no evidence of recurrence (participants with stable untreated cancer are not excluded).
- Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version of the 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 4 weeks prior to the start of screening, or five half-lives...
- A learning disability or developmental delay.
- Participants whom the site PI deems to be otherwise ineligible.
- A known allergy to the investigational drug or any of its components. Inactive ingredients of the investigational medicinal product:
- Silicified microcrystalline cellulose
- Dibasic calcium phosphate dihydrate
- Mannitol
- Stearic acid
- Hypromellose (capsule shells structure)
- Titanium dioxide (opacifier of the capsule shells)
- Is currently pregnant, breast-feeding, and/or lactating.
- Uncontrolled hypertension (systolic \>160mmHg and/or diastolic \>95mmHg) or hypotension (systolic \<90mmHg and/or diastolic \<60 mmHg) and deemed medically significant by the PI.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Sun City, Arizona, United States
- Fountain Valley, California, United States
- Englewood, Colorado, United States
- Stamford, Connecticut, United States
- Aventura, Florida, United States
- Daytona Beach, Florida, United States
- DeLand, Florida, United States
- Ocala, Florida, United States
- Tampa, Florida, United States
- Winter Park, Florida, United States
- Decatur, Georgia, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- Farmington Hills, Michigan, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Tulsa, Oklahoma, United States
- Willow Grove, Pennsylvania, United States
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Sun City, Arizona, United States; Fountain Valley, California, United States; Englewood, Colorado, United States; Stamford, Connecticut, United States; Aventura, Florida, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.