EVALUATION OF THE EFFICACY OF ADD-ON MEMANTINE TREATMENT FOR PARKINSONS DISEASE-A OPEN LABEL RANDOMIZED CONTROLLED CLINICAL STUDY
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- improvement in parkinsonism and dyskinesias with quality of life assessed by UPDRS, DRS, MMSC, PD quality of life scales
研究概览
简要总结
1. DETAILS OF THE RESEARCH PLAN:
— AIM: To compare the efficacy of Memantine as an add-on treatment with Levodopa in Patients with Parkinson’s disease compared with Levodopa alone.
— OBJECTIVES:
- To evaluate whether Memantine as an add-on treatment to Levodopa
improve UPDRS (Unified Parkinson’s Disease Rating Scale) SCALE.
- To evaluate Whether Memantine as an add-on treatment to Levodopa
improve QUALITY OF LIFE.
-
To evaluate whether memantine improves Levodopa induced dyskinesias.
-
To evaluate whether memantine improves non- motor symptoms of Parkinson’s disease.
— HYPOTHESIS: Memantine as an add-on treatment with Levodopa may improve symptoms of Parkinsonism and quality of life by increasing of 20% difference compared with Levodopa alone.
— IMPORTANCE OF THE RESEARCH PROPOSAL:
· Parkinson’s Disease is a Degenerative disorder of the central nervous system.
· Mainly affecting the motor system.
· Anti parkinson’s treatment should be started at the earliest to minimize the effects of motor defects.
· Though many drugs are available for parkinson’s diseases, they have many side effects.
· The standard drug therapy for parkinson’s disease is levodopa which can produce dyskinesias.
· Memantine is found to improve motor symptoms and reduces levodopa induced dyskinesias as reported in previous studies.
· Memantine also a well – tolerated drug compare with other drugs with less side effects as reported.
· Thus the importance of the current thesis is to evaluate the efficacy of add on memantine treatment for prakinsons disease.
Methods : It will be a prospective, observational and comparative study comprising of 40 subjects with Parkinson’s Disease who will be admitted at SRM MCH & RC. Based on inclusion and exclusion criteria subjects will be grouped into two. Subjects who received Memantine(20mg/day) and Levodopa(125mg) considered as Group I and Levodopa alone as Group II. Both group consists of 20 subjects in each. Subjects will be followed upto 1 year.
Data Collection: Data will be collected from the patient’s case sheet and will be entered in patient proforma after obtaining permission from the Head of The Department, Neurology. The parameters are
1) Demographic profile: Age, gender, BMI
2) Past medical history, family history, personal history
3) Blood pressure, ECG changes, CBG
4) Blood investigation: CBC,RFT,LFT
5) Adverse reactions- Allergic like reactions
6) Neurological examination, MMSE(Mini Mental State Examination)
7) Time for symptom relief
8) Cost of the drug
9) Duration of hospital stay.
10) UPDRSMotor Score /DRS/ PD Quality of life scale.
Statistical Analysis:
All data will be entered in Microsoft excel sheet and analysis will be done by using Unpaired t test and chisquare test in SPSS software version 17.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with idiopathic PD based on UKPDS Diagnostic Criteria diagnosed Fewer than 7 years 2)Patients Requiring dopaminergic anti-parkinsonism therapy 3)Patients willing to give informed consent.
排除标准
- •Subjects who are currently treated with apomorphine and/or dopamine receptor antagonists 2)Subjects treated with anticholinergic medications or amantadine alone 3) severe dementia 4)Subjects who have undergone a neurosurgical procedure for PD 5)Subjects who have atypical parkinsonism.
结局指标
主要结局
improvement in parkinsonism and dyskinesias with quality of life assessed by UPDRS, DRS, MMSC, PD quality of life scales
时间窗: at the end of each month for 1 year
次要结局
- Improvement in Quality of Life(improvement in memory functions)