A Study of Buntanetap in Participants With PD
An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 42 days
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Qualified participants will receive buntanetap 30mg QD after a screening period of up to 42 days."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This 36-month study tests the long-term safety of buntanetap in people with Parkinson’s disease (PD). It is for invited people from past buntanetap trials and people receiving deep brain stimulation (DBS), a treatment that sends electrical signals to the brain. Participants take 30 mg once a day, and everyone knows they are taking buntanetap.
This study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study. This study will be conducted with two cohorts. Cohort 1 will enroll via invitation only for PD participants who have previously participated in buntanetap clinical trials. Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. Qualified participants will receive buntanetap 30mg QD after a screening period of up to 42 days.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have Parkinson’s disease with no known cause, diagnosed using the study’s rules.
- Group 1: Be invited after taking part in a past buntanetap trial for PD. A legally approved representative is needed if your memory and thinking test score is below 21.
- Group 2: Be age 40–85 and have had successful DBS treatment in one of two allowed brain areas for at least 12 months. Your PD must be stage 1–3 when medicine is working, and your memory and thinking score must be 21–30.
- Have a support person who can come to certain study visits.
- If you can become pregnant, have a negative pregnancy test, do not breastfeed, and use highly effective birth control during treatment and for one month afterward.
- Men must be unable to father a child, be sexually inactive, or agree not to father a child during treatment and for one month afterward. Barrier birth control and highly effective birth control for female partners are required.
- Keep allowed medicines unchanged for at least four weeks before screening. If taking seizure medicines, have no breakthrough seizures in the past three years.
- Have no current thoughts of suicide or suicide attempt in the past month. Be in good general health and able to see and hear well enough to complete study tests.
Who can't join
- Group 1: Currently receive DBS treatment. You may qualify for Group 2 instead.
- Have a mental health disorder unless symptoms are mild and stable on treatment, or treatment is no longer needed; a seizure disorder not stable on medicine; or a learning disability or developmental delay.
- Have certain heart rhythm problems, a medically serious heart rate below 50 or above 100 beats per minute, or medically serious high or low blood pressure outside the study’s limits.
- Have uncontrolled diabetes, serious kidney or liver problems, or other important abnormal lab results.
- Be at immediate risk of harming yourself or others, have thoughts of suicide with intent in the past two months, or have suicidal behavior in the past six months.
- Have cancer now or within the past year, unless treated with no sign it has returned or stable without treatment. Have a moderate or severe alcohol or drug use disorder in the past five years.
- Have taken another study drug too recently, usually within four weeks before screening or longer for drugs that stay in the body longer. This does not apply if you are known to have received only a placebo, which has no active drug.
- Be pregnant or breastfeeding, be allergic to buntanetap or any ingredient, or be judged unable to join by the study doctor.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. 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 representative is required for any participant whose MMSE \<21 at screening. b. Cohort 2: Has been receiving DBS treatment in either 1) the subthalamic nucleus or 2) the globus pallidus internus for at least 12 months after a successful DBS surgery that achieved the goal. i. Female or male adults aged 40 to 85 years. ii. H\&Y stage 1-3 in ON state. iii. MMSE 21-30 at screening and baseline. 2. Have a support person who will accompany the participant on study visits at designated times. 3. 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 a failure rate of less than 1% per year when used consistently and correctly) during the trial and for one month after the last dose of trial treatment, such as: 1. Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation, 2. Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation, 3. Intrauterine device (IUD), 4. Intrauterine hormone-releasing system (IUS), 5. Bilateral tubal occlusion, 6. 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, an additional highly effective method of contraception should be used), 7. 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 reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant). * 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 4. 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. Female partners of male participants must adopt a highly effective method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as: 1. Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation, 2. Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation, 3. IUD, 4. IUS, 5. Bilateral tubal occlusion. 5. No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the C-SSRS. 6. 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. 1. Standard of care anti-parkinsonian medication, 2. Cholinesterase inhibitors and/or memantine medication, 3. Anticonvulsant medications used for epilepsy or mood stabilization, or neuropathic pain indications, and have not had a breakthrough seizure 3 years prior to screening, 4. Mood-stabilizing psychotropic agents including, but not limited to, lithium, 7. Adequate visual and hearing ability (physical ability to perform all the study assessments). 8. Good general health with no disease expected to interfere with the study. Exclusion Criteria: 1. Cohort 1 only: Is currently receiving DBS treatment. (Participant may enroll in Cohort 2 if they meet the corresponding inclusion/exclusion criteria). 2. 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), unless their symptoms have been mild, and they are stable on treatment or no longer need treatment. Mild depression or history of depression that is stable on treatment with selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) medication at a stable dose is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications. 3. 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. 4. 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. 5. Bradycardia (\<50 bpm) or tachycardia (\>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 6. 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. 7. Clinically significant renal (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] \<50 mL/min/BSA \[body surface area\]) or hepatic impairment (Alkaline phosphatase \[ALP\] \> 2.0X the upper limit of normal \[ULN\] and/or total bilirubin \> 2.0X ULN). 8. 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. 9. 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 intent, with or without a plan or method (e.g., positive response to Items 4 or 5 in assessment of suicidal ideation on C-SSRS) in the past 2 months, or suicidal behavior in the past 6 months. 10. 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). 11. Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version of the DSM. 12. 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 of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. 13. A learning disability or developmental delay. 14. Participants whom the site PI deems to be otherwise ineligible. 15. 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) 16. Is currently pregnant, breast-feeding, and/or lactating. 17. Uncontrolled hypertension (systolic \>160mmHg and/or diastolic \>95mmHg) or hypotension (systolic \<90mmHg and/or diastolic \<60 mmHg) and deemed medically significant by the PI.
Study sites (27)
AL
- University of Alabama at Birmingham · Birmingham, AL 35233Candace Cromer · Study contact · 205-996-4034 · candacecromer@uabmc.eduNatividad Stover, M.D. · Principal investigatorMore trials in Birmingham
AZ
- Banner Sun Health Research Institute - Cleo Roberts Center for Clinical Research · Sun City, AZ 85351Serena Lowery · Study contact · 623-832-6500 · serena.lowery@bannerhealth.comSara Dhanani, M.D. · Principal investigatorMore trials in Sun City
CA
- Parkinson's & Movement Disorder Institute (PMDI) - Orange County Office · Fountain Valley, CA 92708Evan Moreno-Davis · Study contact · 714-378-5074 · evan@pmdi.orgDaniel Truong, M.D. · Principal investigatorMore trials in Fountain Valley
CO
- Cenexel Rocky Mountain Clinical Research · Englewood, CO 80113Sally Modzelewski · Study contact · 720-776-0092 · s.modzelewski@cenexel.comMeagen Salinas, M.D. · Principal investigatorMore trials in Englewood
CT
- New England Institute for Clinical Research (Ki Health Partners) · Stamford, CT 06824Valerija Misev · Study contact · 203-914-1903 ext. 125 · Valerija@neinh.comPeter McAllister, M.D. · Principal investigatorMore trials in Stamford
FL
- First Choice Neurology - Aventura Neurologic Associates · Aventura, FL 33180Jonathan Palmquist · Study contact · 786-744-5596 · jpalmquist@vintrials.comJonathan Cross, M.D. · Principal investigatorMore trials in Aventura
- Arrow Clinical Trials · Daytona Beach, FL 32117Vinoothna Moluguri · Study contact · 386-316-6152 · vmoluguri@arrowtrials.comDavid Billmeier, M.D. · Principal investigatorMore trials in Daytona Beach
- Accel Clinical Sites-Georgia LLC dba Accel Research Sites-Lake Oconee CRU · DeLand, FL 32720Erica Santoni · Study contact · 386-785-2400 ext. 4608 · erica.santoni@accelclinical.comBruce Rankin, D.O. · Principal investigatorMore trials in DeLand
- Renstar Medical Research · Ocala, FL 34470Sebastian Mesa · Study contact · 352-629-5800 · sebastian.mesa@renstar.netAnnette Nieves, M.D. · Principal investigatorMore trials in Ocala
- University of South Florida (USF) - University of South Florida College of Medicine - Parkinson's Di · Tampa, FL 33613Erica Botting · Study contact · 813-974-8026 · ericabotting@usf.eduRobert Hauser, M.D., MBA · Principal investigatorMore trials in Tampa
- Conquest Research · Winter Park, FL 32789Fabiola Perez · Study contact · 407-916-0060 · fabiola.perez@conquestresearch.comRekha Gandhi, M.D. · Principal investigatorMore trials in Winter Park
GA
- iResearch Atlanta · Decatur, GA 30030Elizabeth Davis · Study contact · 404-537-1281 · e.davis@cenexel.comKimball Johnson, M.D. · Principal investigatorMore trials in Decatur
IN
- Josephson Wallack Munshower Neurology, P.C. · Indianapolis, IN 46256Tammy Root · Study contact · 317-573-6061 · troot@jwmneuro.comKristi George, M.D. · Principal investigatorMore trials in Indianapolis
KS
- University of Kansas Medical Center (KUMC) - School of Medicine - Parkinson's Disease and Movement D · Kansas City, KS 66160Kelly Lyons · Study contact · 913-588-7159 · klyons@kumc.eduRajesh Pahwa, M.D. · Principal investigatorMore trials in Kansas City
MI
- Quest Research Institute · Farmington Hills, MI 48334Savannah Carra · Study contact · 248-957-8940 · savannah.carra@questri.comAaron Ellenbogen, D.O. · Principal investigatorMore trials in Farmington Hills
NC
- Duke Department of Neurosurgery · Durham, NC 27710Vera George · Study contact · 919-668-3885 · vera.george@duke.eduKyle Mitchell, M.D. · Principal investigatorMore trials in Durham
NY
- Mount Sinai Hospital · New York, NY 10019Sofya Glazman · Study contact · 646-493-1862 · sofya.glazman@mountsinai.orgJoohi Jimenez-Shahed, M.D. · Principal investigatorMore trials in New York
OH
- The Ohio State University Wexner Medical Center · Columbus, OH 43210Victoria Miller · Study contact · 614-688-8672 · victoria.miller@osumc.eduZachary Jordan, M.D. · Principal investigatorMore trials in Columbus
OK
- The Movement Disorder Clinic of Oklahoma · Tulsa, OK 74136Elise Gibson · Study contact · 918-392-4530 · mdcclinicaltrials@gmail.comKevin Klos, M.D. · Principal investigatorMore trials in Tulsa
PA
- Abington Neurology · Willow Grove, PA 19090Brian Weingartner · Study contact · 215-957-9250 ext. 130 · brian.weingartner.ana@gmail.comDavid Weisman, M.D. · Principal investigatorMore trials in Willow Grove
SC
- Medical University of South Carolina (MUSC) - The Murray Center for Research on Parkinson's Disease · Charleston, SC 29401Sandra Wilson · Study contact · 843-792-3223 · wilsosan@musc.eduVanessa Hinson, M.D., PhD · Principal investigatorMore trials in Charleston
TN
- Neurology Clinic, P.C. · Cordova, TN 38018Ye Liu · Study contact · 901-747-1111 · yliu@neuroclinic.orgKendrick Henderson, M.D. · Principal investigatorMore trials in Cordova
- Veracity Neuroscience LLC · Memphis, TN 38157Hannah Touliatos · Study contact · 901-604-0345 · hannah@veracityneuroscience.comMark LeDoux, M.D., PhD · Principal investigatorMore trials in Memphis
TX
- Central Texas Neurology · Round Rock, TX 78681Koni Lopez · Study contact · 512-218-1222 · k.lopez@ctncpa.orgElizabeth Peckham, M.D. · Principal investigatorMore trials in Round Rock
VA
- University of Virginia Health System (UVAHS) - Adult Neurology Clinic · Charlottesville, VA 22903Lauren Miller · Study contact · 434-982-6599 · fdk5dn@uvahealth.orgBinit Shah, M.D. · Principal investigatorMore trials in Charlottesville
WA
- Inland Northwest Research · Spokane, WA 99202Aaron Dahl · Study contact · 509-960-2818 · adahl@inwresearch.comJason Aldred, M.D. · Principal investigatorMore trials in Spokane
WI
- Medical College of Wisconsin · Milwaukee, WI 53226Shelby Schold · Study contact · 414-955-0698 · sschold@mcw.eduKaren Blindauer, M.D. · Principal investigatorMore trials in Milwaukee