EUCTR2009-013670-41-CZ进行中（未招募）不适用
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease
Synosia Therapeutics AG0 个研究点目标入组 126 人开始时间: 2009年9月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
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 a confirmed diagnosis of
- •idiopathic Parkinson?s disease (PD), meeting the UK
- •Parkinson?s Disease Society Brain Bank diagnostic criteria
- •[Daniel et al., 1993], of a greater than 1 year duration, who
- •are otherwise healthy and fulfill all of the inclusion criteria
- •and none of the exclusion criteria.
- •2. Age range 40 – 85 years.
- •3. Modified Hoehn and Yahr Stage 2-4.
- •4. Subjects in the fluctuating” stage of PD with an average of at
- •least 2 hours and no more than 6 hours off” time during
- •awake hours from the 24-hour patient diaries taken during the
- •2 consecutive days directly preceding the scheduled
- •Baseline/Day 1 visit.
- •5. Subjects who have been levodopa-responsive for at least
- •1 year and taking at least 4 doses per day (or at least 3 doses
- •per day if 2 or more are a sustained-release formulation).
- •Note: Combination products containing levodopa and
- •levodopa/carbidopa with a COMT inhibitor in one fixed
- •dosage form (Stalevo®) are permitted.
- •6. If receiving allowed anti-Parkinson?s medication(s) other than
- •levodopa, subjects must have been clinically stable on the
- •same dose for a minimum of 30 days before randomization.
- •7. A Unified Parkinson?s Disease Rating Scale (UPDRS) III
- •Motor Examination score greater than 25 in defined off”
- •state at the screening and baseline assessment.
- •8. Mini-mental state examination (MMSE) score greater than 24
- •to rule out dementia.
- •9. Good general health, free from significant co-morbid illnesses
- •that could interfere with evaluation of study drug, as
- •ascertained by detailed medical history and physical and
- •laboratory examinations.
- •10. Able to provide and have signed an Institutional Review
- •Board/Independent Ethics Committee-approved written
- •informed consent form to participate in this study.
- •11. Plasma creatinine less than or equal to 2.2 mg/dL or
- •194 µmol/L.
- •12. Women with no childbearing potential; ie, woman who are
- •surgically sterile or woman who have been post-menopausal
- •for at least 1 year as confirmed by follicle-stimulating
- •hormone (FSH) greater than or equal to 40 mIU/mL or
- •Men who have a sterile or post-menopausal sexual partner or
- •have agreed to use contraception (eg, use of a condom with
- •spermicide or use by partner of oral, implantable or injectable
- •contraceptives, intrauterine device [IUD], diaphragm with
- •spermicide), starting at the time of study drug administration
- •and for a period of 1 month after the end of the study.
- •13. Achieved the following results for PD diary training and
- •baseline diary recordings:
- •a. Completed the protocol-specified diary training during the
- •screening period and achieved at least 75% diary
- 另有 17 项未显示
排除标准
- •1. Atypical or secondary parkinsonism.
- •2. Prior neurosurgical operation for Parkinson?s disease (PD).
- •3. Subjects being treated concomitantly with both a COMT and a
- •MAO-B inhibitor.
- •4. Subjects taking or requiring adjunctive therapy for
- •Parkinson?s disease (PD) with apomorphine.
- •5. Subjects treated with intraduodenal preparations of levodopa
- •(eg, Duodopa) or with intradermal levodopa delivered with a
- •6. Subjects with a dyskinesia score of 3 or 4 on UPDRS subscale
- •IV, Item 33 at the screening or baseline assessment; peak-dose
- •dyskinesia will not exclude otherwise eligible subjects.
- •7. Any 12-lead ECG with any of the following abnormalities at
- •screening: 2nd or 3rd degree heart block, conduction
- •disorders, ventricular and/or atrial arrhythmias; (1st degree
- •bradycardia: non-specific ST and T wave changes are
- •acceptable if reviewed, approved and documented as not
- •clinically significant [NCS] by the Investigator).
- •8. Subjects with active ocular disease (not including cataracts)
- •including but not limited to: infection, inflammation, macular
- •degeneration, optic nerve degeneration.
- •9. History of conjunctivitis, corneal opacity, keratitis,
- •photophobia, or blepharitis in the past 2 years.
- •10. Subjects who have been diagnosed and/or require therapy to
- •treat a psychiatric disorder other than depression including but
- •not limited to Parkinson?s dementia or drug induced
- •hallucinations/paranoia, dementia, schizophrenia or bipolar
- •11. Geriatric Depression Scale (short form) score greater than 8.
- •12. Subjects receiving treatment for depression with antidepressants
- •if they have not been on a stable dose for 30 days
- •prior to randomization.
- •13. Any other condition or clinically significant abnormal
- •findings on the physical or neurological examination (eg,
- •multiple system atrophy, recent stroke), medical and
- •psychiatric history, or clinical laboratory results at screening
- •that, in the opinion of the Investigator, make the subject
- •unsuitable for the study or put the subject at additional risk.
- •14. Potential exposure to SYN118 (Orfadin®, nitisinone) outside
- •the context of the present trial.
- •15. Subjects who require drugs that are inducers of the P450
- •CYP3A4 isoenzyme including, HIV antivirals (efavirenz,
- •nevirapine), barbiturates, carbamazepine, glucocorticoids,
- •modafinil, phenobarbital, phenytoin, rifampin, St. John's
- •wort, troglitazone, oxcarbazepine, pioglitazone, rifabutin.
- •The following site may be referred to in determining whether
- •drugs not listed can induce this enzyme:
- •http://medicine.iupui.edu/clinpharm/ddis/table.asp
- •16. Preparations containing iron and/or amino acids, for example
- •some multi-vitamin/mineral preparations or nutritional
- •supplements.
- •17. Received treatment with any other investigational drug within
- 另有 4 项未显示
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