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CTRI Number  CTRI/2016/08/007159 [Registered on: 05/08/2016] Trial Registered Prospectively
Last Modified On: 11/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the beneficial effects of the drug memantine for patients with parkinsonism 
Scientific Title of Study   EVALUATION OF THE EFFICACY OF ADD-ON MEMANTINE TREATMENT FOR PARKINSONS DISEASE-A OPEN LABEL RANDOMIZED CONTROLLED CLINICAL STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr V Sathyanarayanan  
Designation  Professor of pharmacology 
Affiliation  SRM University 
Address  SRM Medical College potheri kattankulathur Kancheepuram TAMIL NADU 603203 India
A 601 medical staff quarters,srm medical college, potheri, kattankulathur post ,kanchipuram district
Kancheepuram
TAMIL NADU
603203
India 
Phone  919384633405  
Fax    
Email  satya672000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kabilan K 
Designation  PG student  
Affiliation  SRM University 
Address  SRM Medical College potheri kattankolathur Kancheepuram TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone    
Fax    
Email  drkabilanvtm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kabilan K 
Designation  PG student  
Affiliation  SRM University 
Address  SRM Medical College potheri kattankolathur Kancheepuram TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone    
Fax    
Email  drkabilanvtm@gmail.com  
 
Source of Monetary or Material Support  
SRM University 
 
Primary Sponsor  
Name  SRM University  
Address  Potheri Kattankulathur Kancheepuram  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kabilan K   Neurology ward, department of Neurology, SRM Hospital  SRM Medical College Hospital and Research Centre potheri kattankulathur post Kancheepuram district PIN 603203 TAMIL NADU
Kancheepuram
TAMIL NADU 		 9884678333

dr.kabilanvtm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Parkinsonism, (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  levodopa  levodopa 125mg tablets once daily orally for one year. 
Intervention  Memantine and levodopa  Add on memantine tablets 20 mg once daily orally for 1 year with levodopa tablets 125 mg once daily orally for one year. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)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
 
 
ExclusionCriteria 
Details  1) 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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
improvement in parkinsonism and dyskinesias with quality of life assessed by UPDRS, DRS, MMSC, PD quality of life scales  at the end of each month for 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Quality of Life
improvement in memory functions 		 at the end of each month for 1 year 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   22/08/2016 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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: 

1. To evaluate whether Memantine as an add-on treatment to Levodopa  

    improve UPDRS (Unified Parkinson’s Disease Rating Scale) SCALE.

2. To evaluate Whether Memantine as an add-on treatment to Levodopa

    improve QUALITY OF LIFE.

3. To evaluate whether memantine improves Levodopa induced dyskinesias.

4. 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)   UPDRS Motor 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.


 
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