A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD
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|ClinicalTrials.gov Identifier: NCT05357989|
Recruitment Status : Recruiting
First Posted : May 3, 2022
Last Update Posted : September 21, 2022
The purpose of this study is to measure safety and efficacy of buntanetap 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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease, Idiopathic||Drug: Buntanetap Drug: Placebo||Phase 3|
450 early Parkinson's Disease (PD) patients will be randomized to 10mg, 20 mg of Buntanetap or placebo. They will undergo a Screening Visit, and if they provide informed consent and are considered eligible per the inclusion and exclusion criteria, will proceed to participate in the treatment period. Randomized participants will visit the clinic for the first-time dosing in clinic with administration of 10 mg or 20mg of Buntanetap or Placebo, followed by an at home dosing period of 6 months, with daily administration of 10 mg or 20mg of Buntanetap or Placebo. Participants will be required to visit clinics 1 month, 2 months, 3 months, and 6 months (end-of-trial), where they will undergo study procedures that include safety assessments (AE and concomitant medication monitoring, 12-lead ECGs, clinical laboratory testing, vital signs assessments, and physical examinations) and psychometric tests (MDS-United Parkinson's Disease Rating Scale (MDS-UPDRS), Clinical Global Impression of Severity (CGIS), Wechsler Adult Intelligence Scales (WAIS), Mini-Mental State Examination (MMSE)) and Participant Global Impression of Change (PGIC). At the end of blood sampling, the subjects will need to stay for a minimum of 1 hour of observation. After all end-of-study procedures are complete, the subject will be discharged to home. A 24-hour follow-up call will occur after all clinical visits to assess the participants current condition and if there are any additional adverse events to report.
Buntanetap has shown to improve PD subjects' mobility. MDS-UPDRS sum of score of Part II + Part III and Total score of all four parts will be measured to assess its improvement on PD subjects daily living, mobility and complications. PGIC will also be measured to assess its effect.
Buntanetap has shown to reduce inflammation and preserve axonal integrity and synaptic functions as well as neurotoxic proteins in previous Phase 2a studies. In this study we plan to measure plasma GFAP, NFL and potentially TDP43.
Reports of adverse events (AEs) and serious adverse events (SAEs) during exposure to buntanetap will be collected to evaluate if there are any significant clinical safety issues for the study population. Extensive clinical and laboratory safety data already exist for buntanetap; therefore, these safety measures will be sufficient in the proposed study.
For clinical, functional, and cognitive assessment measures, The subjects will be administered the Hoehn & Yahr and the MMSE for determination of inclusion into the study. The MDS-UPDRS and PGIC will be administered for subjects' movement and daily function. The Coding subtest from the WAIS 4th edition will serve as a sensitive measure of Central Nervous System (CNS) dysfunction. MMSE will also be measured to assess subjects' cognitive change.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 6-month Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Efficacy, Safety, and Tolerability of Two Different Doses of Buntanetap or Placebo in Patients With Early Parkinson's Disease|
|Actual Study Start Date :||August 3, 2022|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: 10 mg Buntanetap,
Buntanetap 10 mg oral capsule with daily administration for a period of 6 months
HPMC (vegetarian source) capsule shells
Experimental: 20 mg Buntanetap
Buntanetap 20 mg oral capsule with daily administration for a period of 6 months
HPMC (vegetarian source) capsule shells
Placebo Comparator: Placebo
Placebo oral capsule with daily administration for a period of 6 months
HPMC (vegetarian source) capsule shells
- MDS-Unified Parkinson's Disease Rating Scale Part II+III (OFF-state) [ Time Frame: From baseline to end of trial (6 months) ]
The MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy.
The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence). This assessment will be based on a change in the sum of the score from the Activities of Daily Living (ADL) Scale (Part II) and Motor Examination in the Unified Parkinson's Disease Rating Scale (Part III), from Baseline to the End of Trial.
- Safety and tolerability as accessed by physical examinations, vital signs, clinical laboratory test results, electrocardiogram findings, adverse events (AEs) leading to study discontinuation, drug related AEs, severity of AEs and AEs. [ Time Frame: From consent to end of trial (up to 8 months) ]Safety and tolerability as accessed by physical examinations, vital signs, clinical laboratory test results, electrocardiogram findings, adverse events (AEs) leading to study discontinuation, drug related AEs, severity of AEs and AEs. The frequencies of adverse events, serious adverse events, and laboratory abnormalities between the participants across the treatment groups will be compared.
- MDS-Unified Parkinson's Disease Rating Scale Total Score (OFF-state) [ Time Frame: Baseline, 2 months and 6 months visits ]The MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).
- Percentage of Responders with "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (ON-state) [ Time Frame: Baseline, 2 months and 6 months visits ]The participant global impression of change (PGIC) is a participant-reported outcome. The qualitative assessment of meaningful change will be determined by the participant in response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" Scores are 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Percentage of responders with much improved and very much improved on PGIC scale will be assessed. PGIC will be taken at home while the subject is during ON-state (with their standard of care for Parkinson disease).
- Change on Clinical Global Impression of Severity (CGIS) (OFF-state) [ Time Frame: Baseline, 1 month, 2 months, 3 months, and 6 months visits ]The clinical global impressions scale on the severity of movement impairment as assessed by the site rater. Site raters will be asked: Considering your total clinical experience with the Parkinson disease population, how ill is the patient at this time? Answers were based on a 0-7 scale, with 1=not assessed, 2= very mild, 3= mild, 4= moderate, 5= moderate severe, 6= severe, 7=extremely severe.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05357989
|Contact: Melissa A Gainesemail@example.com|
|Contact: Cheng Fang, PhD||(610) firstname.lastname@example.org|