EUCTR2022-001542-38-PL进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Subjects must meet the following criteria:
- •1. Diagnosis of idiopathic PD according to MDS Clinical Diagnostic Criteria for Parkinson’s Disease.
- •2. H&Y score =1, 2 or 3 during ON-state & OFF-state <2hrs per day.
- •3. Male or female aged 40 – 85 years.
- •4. MMSE score between the range of 22-30 during screening visit (ON-state) and subjects can live independently without a caregiver.
- •5. Female subjects 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 4 weeks after the last dose of trial treatment, such as:
- •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, an additional highly effective method of contraception should be used)
- •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.
- •6. 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:
- •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
- •7. General cognition and functional performance sufficiently preserved that the subject can provide written informed consent.
- •8. No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the Columbia Suicide Severity Rating Scale.
- •9. Stability of permitted medications prior to screening for at least 4 weeks.
- •10. At screening subjects do not need to but may be on the following medication:
- •Standard of Care anti-parkinsonian medication (L-dopa or dopamine antagonists)
- •Anticonvulsant medications used for epilepsy or mood stabilization, neuropathic pain indications
- •Mood-stabilizing psychotropic agents, including, but not limited to, lithium.
- •11. Adequate visual and hearing ability (physical ability to perform all the study assessments).
- •12. Good general health with no disease e
排除标准
- •Subjects meeting any of the following criteria must not be included in the study:
- •1. 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 SSRI or SNRI medication at a stable dose is acceptable.
- •2. History of a seizure disorder, if stable on medication is acceptable.
- •3. Has 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.
- •4. Has bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG at screening.
- •5. 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.
- •6. Has clinically significant renal (CKD-EPI <60 mL/min/BSA (body surface area)) or hepatic impairment (ALP > 2.0 ULN and/or total bilirubin > 2.0 ULN).
- •7. 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.
- •8. 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.
- •9. Has cancer or has had a malignant tumor within the past year, except subjects who underwent potentially curative therapy with no evidence of recurrence. (Subjects with stable untreated prostate cancer or skin cancers are not excluded).
- •10. Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version DSM.
- •11. Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 60 days prior to the start of screening. The end of a previous investigational trial is the date the last dose of an investigational agent was taken, or five half-lives of the investigational drug, whichever is greater.
- •12. Subjects with learning disability or developmental delay.
- •13. Subjects whom the site PI deems to be otherwise ineligible.
- •14. Subjects with a known allergy to the investigational drug or any of its components. Here are all the inactive ingredients of the IMP:
- •Silicified Microcrystalline Cellulose
- •Dibasic Calcium Phosphate Dihydrate
- •Magnesium Stearate
- •Hypromellose (capsule shells structure)
- •Titanium Dioxide (opacifier of the capsule shells)
- •15. Subject is currently pregnant, breast-feeding and/or lactating
- •16. Subject is currently taking strong or moderate CYP3A4 inhibitors and/or inducers. See examples below. CYP3A4 inhibitors: Itraconazole, Ketoconazole, Azamulin, Troleandomycin, Verapamil CYP3A4 inducers: Rifampicin
- •17. Subject is currently receiving deep brain stimulation treatment.
研究者
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