EUCTR2010-018534-44-DE进行中（未招募）不适用
A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 408
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. Subjects must provide written informed consent prior to any study procedures being performed.
- •2. Subjects must be able to understand the study requirements and be able and willing to follow any instructions and comply with all scheduled study visits.
- •3. Male or female subjects aged between 35 and 75 years, inclusive at the time of consent.
- •4. Subjects must have a confirmed diagnosis of early-stage idiopathic PD according to the UK PD Society Brain Bank (UKPDSBB) criteria within the 2 years prior to screening.
- •5. Subjects must have a Hoehn and Yahr Score of 1 to 2.5, inclusive and no postural instability.
- •6. Subjects whose clinical condition at the time of study enrolment does not require any PD therapy and, to the investigator's best judgment, will not require such therapy for the next 6 months.
- •7. Female subjects must be of non-child bearing potential: postmenopausal (no menses in the past 12 months and follicle stimulating hormone [FSH] levels > 40 IU/L), hysterectomised or surgically sterilised.
- •8. Male subjects must agree to use two medically acceptable methods of contraception (e.g., double barrier) throughout the study and for 1 month after completing dosing with IMP.
- •9. Subjects must have liver enzymes (aspartate aminotransferase
- •(AST/SGOT), alanine aminotransferase (ALT/SGPT), gamma
- •glutamyltransferase (GGT/?GT),alkaline phosphatase (ALP)) that are lower than or equal to 1.5 times the upper limit of normal (ULN) and total bilirubin values that are lower than or equal to the ULN.
- •10. Subjects must be in good health, with no clinically significant and relevant medical history that could affect the conduct of the study and evaluation of the data, as ascertained by the investigator through detailed medical history and screening assessments.
- •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 286
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 122
排除标准
- •1. Subjects with a diagnosis of atypical Parkinsonism or any known secondary Parkinsonian syndrome.
- •2. Subject has a history of pallidotomy, thalamotomy, deep brain
- •stimulation or foetal tissue transplant or any other neurosurgical
- •3. Subjects with any current or past (in the last 12 months) psychiatric diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text revision (DSM-IV-TR) that might interfere with the subject's ability to perform the study and the required study assessments. This would include alcohol- and drug-related abuse or dependence, dementia (assessed as a mini mental state examination [MMSE] score of < 24), major depression (assessed as BDI-II score =15), schizophrenia, bipolar disorder and mental retardation. Mild depression, anxiety and related disorders would be acceptable, providing they are controlled, any drug treatment (excluding anti-psychotics) has been stable for 4 weeks prior to screening and is expected to remain stable for the duration of the study.
- •4. Subjects currently taking any treatment for PD, including, but not limited to, L-DOPA, catechol-O-methyl transferase (COMT) inhibitors, non-selective monoamine oxidase (MAO) inhibitors, MAO-B inhibitors, dopamine agonists, anti-cholinergics and apomorphine (see also Section 8.1). Subjects that have previously taken any medicinal treatment for PD for a total period not exceeding 4 weeks AND have not taken any medicinal treatment for PD within the 8 weeks prior to screening can be included in the study.
- •5. Exclusion criterion not applicable.
- •6. Subjects receiving concomitant therapy with any of the following medications: St John's Wort, digoxin, warfarin or heparin or have received such medications within 4 weeks prior to screening.
- •7. Subjects with a current or past (in the last 12 months) history of seizure or epilepsy or unexplained loss of consciousness.
- •8. Female subjects who are breast feeding, pregnant, or intending to become pregnant; male subjects whose partner is intending to become pregnant.
- •9. Treatment with any IMP (with the exception of Coenzyme Q10) within12 weeks prior to the screening visit or the equivalent time of six halflives of the IMP, whichever is longer; a 4-week washout is required for subjects who have taken Coenzyme Q10 as an IMP.
- •10. Subjects without a gall bladder.
- •11. Intention to donate blood or plasma during the study or in the 8 weeks after the final dose of IMP.
- •12. A medical history of infection with human immunodeficiency virus, hepatitis C and/or hepatitis B.
- •13. A history of malignancy of any type, other than surgically excised
- •non melanoma skin cancers, within 5 years prior to screening.
- •14. Subjects with poorly controlled insulin dependent or non-insulin dependent diabetes mellitus.
- •15. Subjects who are following a diet that severely restricts
- •carbohydrate intake (ketogenic diets).
- •16. Subjects who are currently taking medium chain triglycerides (MCT)
- •as a dietary supplement or for any other reason.
- •17. Any relevant condition, behaviour, laboratory value or concomitant medication which, in the opinion of the investigator, makes the subject unsuitable for entry into the study.
研究者
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