A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Pa… (NCT05357989) | Clinical Trial Compass
CompletedPhase 3
A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD
United States523 participantsStarted 2022-08-03
Plain-language summary
The purpose of this study is to measure safety and efficacy of buntanetap/posiphen 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
Who can participate
Age range40 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of idiopathic Parkinson Disease according to MDS Clinical Diagnostic Criteria for Parkinson's Disease.
✓. H\&Y score =1, 2 or 3 during ON-state \& OFF-state \<2hrs per day.
✓. Male or female aged 40 - 85 years.
✓. MMSE score between the range of 22-30 during screening visit (ON-state) and subjects can live independently without a caregiver.
✓. Female subjects of childbearing potential\* must have a negative serum or 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 4 weeks after the last dose of trial treatment, such as:
✓. Male subjects 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 subject 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:
✓. General cognition and functional performance sufficiently preserved that the subject can provide written informed consent.
✓. No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the Columbia Suicide Severity Rating Scale.
Exclusion criteria
✕. Has a history of a 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). Mild depression or history of depression that is stable on treatment with a selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI) medication at a stable dose is acceptable.
What they're measuring
1
Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state)
✕. History of a seizure disorder, if stable on medication is acceptable.
✕. Has a history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 475ms, or torsades de pointes.
✕. Has bradycardia (\<50 bpm) or tachycardia (\>100 bpm) on the ECG at screening.
✕. Has uncontrolled Type-1 or Type-2 diabetes. A subject with HbA1c levels up to 7.5% can be enrolled if the investigator believes the subject's diabetes is under control.
✕. Has clinically significant renal or hepatic impairment.
✕. Has any clinically significant abnormal laboratory values. Subjects with liver function tests (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) greater than twice the upper limit of normal 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. Subjects 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 the C SSRS) in the past 2 months, or suicidal behavior in the past 6 months.