EUCTR2018-004156-37-CZ进行中（未招募）1 期
A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless
euroDerm Ltd.0 个研究点目标入组 482 人开始时间: 2019年9月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 482
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects with PD of any race at least 30 years of age who sign an Institutional Review Board/Ethics Committee–approved informed consent form (ICF).
- •2. Parkinson’s disease diagnosis consistent with the UK Brain Bank Criteria.
- •3. Modified Hoehn and Yahr scale in ON” stage = 3.
- •4. Subjects must experience motor fluctuations and experience an average of at least 2.5 hours daily (with a minimum of 2 hours every day) in the OFF” state during the waking hours as confirmed by an adequately completed ON/OFF” diary over 3 days.
- •5. Subject treatment should be at least 4 doses/day of LD/ Dopa Decarboxylase Inhibition (DDI) (or at least 3 doses/day of extended release LD/DDI, e.g., Rytary) and at least 400 mg/day of LD, or equivalent according to the conversion table, and, according to the Investigator’s judgement, the subject experiences motor fluctuations that cannot be further improved by adjusting anti-PD medications.
- •6. Subjects and/or study partners have no impediment that may prevent them from operating the pump system.
- •7. Subjects and/or study partners must demonstrate ability to keep accurate diary entries of PD symptoms (ON/OFF” diaries) with at least 75% concordance with the Blinded Efficacy Rater by the end of the diary training session during the Screening Period, including at least 1 OFF assessment.
- •8. Mini Mental State Examination (MMSE) score = 24.
- •9. Female subjects must be surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation); postmenopausal (defined as cessation of menses for at least 1 year); or willing to practice a highly effective method of contraception. All female subjects must be non-lactating and not pregnant and have a negative urine pregnancy test at Screening and at Enrollment (IR D1/ V2). Female subjects of childbearing potential must practice a highly effective method of contraception (such methods
- •include combined [estrogen and progestogen containing] hormonal
- •contraception associated with inhibition of ovulation: oral / intravaginal;
- •transdermal / progestogen-only hormonal contraception associated with
- •inhibition of ovulation: oral / injectable; implantable / intrauterine
- •device [IUD] / intrauterine hormone-releasing system [IUS]/ bilateral
- •tubal occlusion / vasectomized partner/ sexual abstinence) from 1 month before Enrollment (IR D1/ V2) until 1 month after the last dose of study treatment. Alternatively, true abstinence is acceptable when it is in line with the subject’s preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, the subject and sexual partner must comply with the contraceptive requirements detailed above.
- •10. Willingness and ability to comply with study requirements.
- •11.Subjects must have a named study partner that signed the ICF.
- •12.Approval for entry into the study by an independent EAC.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 207
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 275
排除标准
- •1. Atypical or secondary Parkinsonism.
- •2. Acute psychosis or troublesome hallucinations in the past 6 months.
- •3. Subjects with clinically significant or unstable medical, surgical, or psychiatric condition or laboratory abnormalities which, in the opinion of the Investigator or the EAC, represents a safety risk, makes the subject unsuitable for study entry, or potentially unable to complete all aspects of the study.
- •4. Clinically significant ECG abnormalities.
- •5. Renal or liver dysfunction that may alter drug metabolism including Screening Visit serum levels of creatinine > 1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 × upper limit of normal, and total bilirubin > 2.5 mg/dL.
- •6. Any malignancy in the 5 years before enrollment, except basal cell carcinoma of the skin, squamous cell carcinoma in situ, or cervical carcinoma in situ that have been successfully treated.
- •7. Use of subcutaneous (SC) apomorphine injections, sublingual apomorphine, or inhaled LD within 4 weeks before the enrollment.
- •8. Concomitant therapy or within 28 days before enrollment with: metoclopramide, reserpine, methylphenidate, or amphetamines, well as neuroleptics; exception in case of Quetiapine and Pimavanserin use: (1) allowed only in case it had been used for a period of at least 3 months before enrollment, (2) subject is on stable therapy for at least 3 months (3) underlying psychosis to be under control and anticipating no changes to the dosage of the medication throughout the study.
- •9. Subjects with a history of alcohol or substance abuse within the past 12 months.
- •10. Subjects who have taken experimental medications within 30 days before enrollment.
- •11.Subjects who have previously participated in studies ND0612H-006 and/or ND0612H-012.
- •12.Subjects who have previously undergone treatment for PD with a surgical intervention (e.g., pallidotomy, thalamotomy, transplantation, deep brain stimulation procedures, gene therapy), Duodopa®/Duopa®, or continuous dopaminergic or apomorphine infusion. Subjects who have discontinued Duodopa®/Duopa® treatment at least 6 months before enrollment and have undergone stoma closure surgery at least 6 months before enrollment, may be included in this study. Subjects who are planning to undergo treatment for PD with a surgical intervention will be enrolled at the Investigator’s discretion.
- •13.Subjects with severe disabling dyskinesias, based on Investigator's discretion.
- •14.History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of different lesions (e.g., sunburn, acne, scar tissue, tattoo, open wound, branding, or pigmentation) that, in the Investigator's opinion, would interfere with the infusion of the study drug or could interfere with study assessments.
- •15.Subjects who do not have sufficient SC tissue for SC infusion treatment.
- •16.Use of non-selective monoamine oxidase inhibitors (e.g., phenelzine, isocarboxazid, tranylcypromine) within 4 weeks before enrollment.
- •17.Use of monoamine-depleting agents (e.g., reserpine, tetrabenazine, deutetrabenazine, valbenazine, xenazine) within 4 weeks before enrollment.
- •18.Current or previous diagnosis of Dopamine Dysregulation Syndrome or Impulse Control Disorder.
- •19. Impulse control disorder within the past 2 years if considered clinically significant by the investigator.
- •20.Subjects who answered yes” to questions 4 or 5 of the C-SSRS within the last 5 years.
- •21.Known allergy to the stu
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