E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic Parkinson's disease |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Main objective : measurement of N-Methyl-Nicotinamide in urine and ATP Complex I in blood of patients with early Parkinson’s disease and non Parkinson’s patients |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Ÿ Men and women with Idiopathic Parkinson’s Disease within 2 years of presentation.( early stage of the disease) Ÿ Presence of at least two symptoms (resting tremor, bradykinesia, rigidity) which are asymmetric.( main criteria of diagnosis for Parkinson’s disease) Ÿ Women 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) Ÿ Age > 40 years.( excluding early presentation of familiar Parkinson’s disease) Ÿ Willing and able to give written consent. Ÿ Willing to comply with the trial’s requirements.( essential ) Ÿ Subjects on monotherapy treatment only with or without dopamine agonists for no longer than two years prior to enrollment.( indicating early stage)
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E.4 | Principal exclusion criteria |
Ÿ Use of any food supplements with Nicotinamide longer than three months prior to enrollment.( otherwise will bias the baseline values) Ÿ Use of centrally acting drugs Methyldopa and Monoxidine.( interference with Nicotinamide metabolism in the brain) Ÿ Patients with pancreatic insufficiency.( due to impaired vitamin absorption) Ÿ Patients with hepatic dysfunction of any cause.( unpredictable and unsafe metabolism of Nicotinamide) Ÿ Use of drugs interfering with mitochondria function such as Methylphenidate. (due to antagonism for site of action with Nicotinamide) Ÿ Under a variable drug dosage regime with effect on central nervous system such as, anxiolytics, hypnotics, and antidepressants. (unpredictable interactions with Nicotinamide) Ÿ Patients with drug induced Parkinson’s disease. Ÿ The presence of dementia with a Mini Mental Test score of less than 20.(alternative diagnosis or late stage of disease) Ÿ Presence of severe depression with Hamilton Depression Scale of more than 10 ( no available data of safety of Nicotinamide in severely depressed patients) Ÿ A modified Hoehn and Yahr score of more than 2.0.( indicator of late stage) Ÿ The use of appetite suppressants or weight lowering medication, such as Xenical (Orlistat) or Reductil (Sibutramine).( central interaction of these drugs) Ÿ A history of more than two Transient Ischaemic Attacks and or Strokes. (indicating vascular etiology of the disease) Ÿ Active Epilepsy.( no data in safety using Nicotinamide above daily recommended dosage which is 40mgs) Ÿ Active Peptic Ulcer Disease. (Nicotinamide might worsen the ulcer) Ÿ The 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) Ÿ Any active Psychiatric disorder.( not able to give consent)
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E.5 End points |
E.5.1 | Primary end point(s) |
N-Methyl Nicotinamide levels in urine and ATP complex I in blood measurements |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |