Idiopathic Parkinson's disease
Conditions
Interventions
Trade Name: Nicotinamide
Product Name: NICOTINAMIDE
Pharmaceutical Form: Tablet
INN or Proposed INN: Nicotinamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10
Sponsors
Queen Elizabeth Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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) 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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: NONE;Primary end point(s): N-Methyl Nicotinamide levels in urine and ATP complex I in blood measurements | — |
Countries
United Kingdom
Outcome results
None listed