EUCTR2004-005034-39-GB进行中（未招募）不适用
icotinamide,vitamin B3, metabolic pathways in patients with early idiopathic parkinson's disease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •ŸMen and women with Idiopathic Parkinson’s Disease within 2 years of presentation.( early stage of the disease)
- •ŸPresence of at least two symptoms (resting tremor, bradykinesia, rigidity) which
- •are asymmetric.( main criteria of diagnosis for Parkinson’s disease)
- •ŸWomen must be either postmenopausal, sterilized or be on a contraceptive regime
- •for at least two months prior the randomization.( Nicotinamide dose more than 40 mgs is not recommended in pregnancy)
- •ŸAge > 40 years.( excluding early presentation of familiar Parkinson’s disease)
- •ŸWilling and able to give written consent.
- •ŸWilling to comply with the trial’s requirements.( essential )
- •ŸSubjects on monotherapy treatment only with or without dopamine agonists for no longer than two years prior to enrollment.( indicating early stage)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •ŸUse of any food supplements with Nicotinamide longer than three months prior to
- •enrollment.( otherwise will bias the baseline values)
- •ŸUse of centrally acting drugs Methyldopa and Monoxidine.( interference with Nicotinamide metabolism in the brain)
- •ŸPatients with pancreatic insufficiency.( due to impaired vitamin absorption)
- •ŸPatients with hepatic dysfunction of any cause.( unpredictable and unsafe metabolism of Nicotinamide)
- •ŸUse of drugs interfering with mitochondria function such as Methylphenidate.
- •(due to antagonism for site of action with Nicotinamide)
- •ŸUnder a variable drug dosage regime with effect on central nervous system such as, anxiolytics, hypnotics, and antidepressants. (unpredictable interactions with Nicotinamide)
- •ŸPatients with drug induced Parkinson’s disease.
- •ŸThe presence of dementia with a Mini Mental Test score of less than 20.(alternative diagnosis or late stage of disease)
- •ŸPresence of severe depression with Hamilton Depression Scale of more than 10 ( no available data of safety of Nicotinamide in severely depressed patients)
- •ŸA modified Hoehn and Yahr score of more than 2.0.( indicator of late stage)
- •ŸThe use of appetite suppressants or weight lowering medication, such as Xenical
- •(Orlistat) or Reductil (Sibutramine).( central interaction of these drugs)
- •ŸA history of more than two Transient Ischaemic Attacks and or Strokes. (indicating vascular etiology of the disease)
- •ŸActive Epilepsy.( no data in safety using Nicotinamide above daily recommended dosage which is 40mgs)
- •ŸActive Peptic Ulcer Disease. (Nicotinamide might worsen the ulcer)
- •ŸThe presence of serious disorders such as; unstable angina, Heart Failure, Severe Chronic Obstructive Pulmonary Disease (COPD), Renal Failure and any chronic
- •debilitating disorders.( unpredictable Nicotinamide metabolism and energy
- •requirements for each subject)
- •ŸAny active Psychiatric disorder.( not able to give consent)
研究者
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