FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076273 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A trial on effect of the drug safinamide on pain in Parkinsons disease patients. 
Scientific Title of Study   Effect of Safinamide on Pain in Idiopathic Parkinsons Disease A Randomized Double blind Placebo Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manyem Manoj 
Designation  senior resident, Department of neurology 
Affiliation  Jipmer 
Address  2nd floor, ward 148 super speciality block, JIPMER, Pondicherry, India.
Room A4, OPD block, first floor, super speciality block, JIPMER, Pondicherry, India.
Pondicherry
PONDICHERRY
605006
India 
Phone  7673954041  
Fax    
Email  manojchowdarymanyam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramkumar S  
Designation  Associate Professor, Neurology 
Affiliation  Jipmer 
Address  2nd floor, ward 148 super speciality block, JIPMER, Pondicherry, India.
Room A4, OPD block, first floor, super speciality block, JIPMER, Pondicherry, India.
Pondicherry
PONDICHERRY
605006
India 
Phone  9894891561  
Fax    
Email  ramkumar.sugumaran@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramkumar S  
Designation  Associate Professor, Neurology 
Affiliation  JIPMER 
Address  2nd floor, ward 148 super speciality block, JIPMER, Pondicherry, India.
Room A4, OPD block, first floor, super speciality block, JIPMER, Pondicherry, India.
Pondicherry
PONDICHERRY
605006
India 
Phone  9894891561  
Fax    
Email  ramkumar.sugumaran@gmail.com  
 
Source of Monetary or Material Support  
JIPMER intra mural research fund, JIPMER hospital, Pondicherry, India, Pin code: 605006 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER hospital, Pondicherry, India, Pin code: 605006 
Type of Sponsor  Government medical college 
 
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 
Dr Manyem Manoj  JIPMER hospital  ward 148, 2nd floor, Department of neurology, super speciality block.
Pondicherry
PONDICHERRY 		 7673954041

manojchowdarymanyam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee (Human studies) for interventional studies, JIPMER pondicherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Administered orally, under double blind conditions. For the first two weeks placebo 50 mg tablets given and participants to take one tablet daily. From the third week participants will be provided placebo 100 mg tablets, one tablet to be taken daily for 10 weeks. Then after 12 weeks placebo will be tapered to dose of 50 mg per day for a week and to be stopped. 
Intervention  Safinamide  Administered orally, under double blind conditions. For the first two weeks safinamide 50 mg tablets given and participants to take one tablet daily. From the third week participants will be provided safinamide 100 mg tablets, one tablet to be taken daily for 10 weeks. Then after 12 weeks safinamide will be tapered to dose of 50 mg per day for a week and to be stopped.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients who are diagnosed with IPD(Idiopathic parkinsons disease)

2. Patients with IPD with age 30 years and above with a minimum KPPS score greater than and equal to 4 as well as moderate pain in one of the seven subdomains of the KPSS. Pain must be related to PD and not explained by any other health problem, like Eg: peripheral neuropathy, organ disease, pain related to arthritis etc. Patients can be included if the intensity of these PD unrelated pains are aggravated by PD.

3. Receiving treatment with a stable dose of oral levodopa which includes controlled release, immediate release or a combination of controlled release and immediate release medication or dopamine agonists for at least 4 weeks before randomization.

 
 
ExclusionCriteria 
Details  1. Patients with other types of parkinsonism, atypical and drug induced.

2. Patients with a diagnosis of or those meeting DSM-V criteria for major depression disorder, Schizophrenia, Bipolar disorder, Substance abuse disorder, other psychotic disorder which requires treatment with anti-psychotic medication.

3. Patients with history of dementia, and cognitive dysfunction

4. Known chronic headache disorder such as chronic migraine more than 15 days a month or cancer related pain.

5. Ophthalmologic diseases like severe hypertensive diabetic/hypertensive retinopathy, inherited or familial retinopathies.

6. Patients with child-pugh score moderate or severe liver failure

7. Contraindications, drug allergy/sensitivity, or intolerance to safinamide.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The difference in change of pain scores at 12 weeks using the Kings Parkinsons disease Pain Scale between patients with IPD using safinamide and placebo  baseline and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The difference in change of pain scores using the KPPS at 6 weeks between patients with Idiopathic Parkinsons disease using Safinamide and placebo  baseline and 6 weeks 
The difference in change of scores in quality of life using Parkinsons disease quality of life questionnaire (PDQ-39) between patients with IPD using Safinamide and placebo.  baseline, 6 weeks and 12 weeks 
The difference in change of scores of Non-motor symptoms using Non motor symptoms scale [NMSS] between patients with IPD using Safinamide and placebo.  baseline, 6 weeks and 12 weeks 
The difference in change of scores in motor symptoms using Unified Parkinson disease rating scale- UPDRS III between patients with IPD using Safinamide and placebo  baseline, 6 weeks and 12 weeks 
The difference in change of scores of patient global impression of change (PGI-C) between patients with IPD using Safinamide and placebo.   baseline, 6 weeks and 12 weeks 
The difference in change of scores of clinical global impression of improvement (CGI-I) between patients with IPD using Safinamide and placebo.  baseline, 6 weeks and 12 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/12/2024 
Date of Study Completion (India) 10/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Other than the optimization of anti-parkinsonian treatment, additional pain treatment strategies are needed to properly address pain management in PD. There are no placebo controlled RCTs with Safinamide on pain in Idiopathic Parkinson’s disease (IPD) patients. Despite its significance the various mechanisms of underlying pain in PD is often poorly understood and therapeutic management is a challenge. So, there is a need to conduct studies on the effects of safinamide on pain in IPD patients. Study will be started after obtaining Institute ethics committee approval. Patients who satisfy the eligibility criteria will be enrolled in the study. The patient will be provided information about the study and explicit consent will be taken. Once patient is willing to participate, appointment will be fixed as per convenience of the patient.  At the beginning of the study KPPS, UPDRS III, PDQ-39, NMSS will be recorded. Patients will be then randomized into the Safinamide or place-bo groups. Safinamide and placebo will be supplied in identical (50 mg) strips taken for two weeks, once daily in the morning. Then safinamide and placebo will be provided in identical (100 mg) strips and continued for further ten weeks. KPPS, UPDRS 3, PDQ-39, NMSS, patient global impression of change (PGI-C) score, and clinical global impression of improvement (CGI-I) score will be re-peated at 6 weeks. After 12 weeks, safinamide and placebo will be tapered to doses of 50 mg and stopped in a week. Subjects will be contacted by telephone once a week to check for adverse effects and compliance. KPPS, UPDRS III, NMSS, PDQ-39, PGI-C, and CGI-I will be repeated at the end of 12 weeks for comparison. Patients and investigators will be unaware of treatment allocation at all times. If any of the study subjects have an exacerbation of pain during the study period and if it is severe, present daily for more than 2 weeks unblinding will be done and they will be treated symptomatically.

 
Close