FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/10/028651 [Registered on: 27/10/2020] Trial Registered Prospectively
Last Modified On: 26/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   New combination treatment for late fatal complication of measles (SSPE) 
Scientific Title of Study   Sofosbuvir and Ribavirin in Subacute Sclerosing Panencephalitis 
Trial Acronym  SR-SSPE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Sharma 
Designation  Clinical Director and Head, Department of Neurology 
Affiliation  Ramkrishna Care Medical Sciences Pvt. Ltd. Raipur (CG)  
Address  Aurobindo Enclave, Pachpedi Naka, Dhamtari Road, Raipur (CG)

Raipur
CHHATTISGARH
492001
India 
Phone  9893137662  
Fax  0771-4004037  
Email  drsanjaysharma12345@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Sharma 
Designation  Clinical Director and Head, Department of Neurology 
Affiliation  Ramkrishna Care Medical Sciences Pvt. Ltd. Raipur (CG)  
Address  Aurobindo Enclave, Pachpedi Naka, Dhamtari Road, Raipur (CG)


CHHATTISGARH
492001
India 
Phone  9893137662  
Fax  0771-4004037  
Email  drsanjaysharma12345@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjay Sharma 
Designation  Clinical Director and Head 
Affiliation  Ramkrishna Care Medical Sciences Pvt. Ltd. 
Address  Department of Neurology Aurobindo Enclave, Pachpedi Naka, Dhamtari Road, Raipur (CG)

Raipur
CHHATTISGARH
492001
India 
Phone  9893137662  
Fax  0771-4004037  
Email  drsanjaysharma12345@gmail.com  
 
Source of Monetary or Material Support  
Ramkrishna Care Medical Sciences Pvt. Ltd. Raipur (CG)  
 
Primary Sponsor  
Name  Dr Sanjay Sharma 
Address  Clinical Director and Head Department of Neurology Ramkrishna Care Medical Sciences Pvt. Ltd. Raipur (CG) Phone No. 9893137662 Email ID: drsanjaysharma12345@gmail.com  
Type of Sponsor  Other [Self] 
 
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 Sanjay Sharma  Ramkrishna Care Medical Sciences Pvt. Ltd. Raipur (CG)   Neurology Department, Room No. 7, Aurobindo Enclave, Pachpedi Naka, Dhamtari Road, Raipur (CG)
Raipur
CHHATTISGARH 
9893137662
0771-4004037
drsanjaysharma12345@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Apollo Hospitals Enterprise Limited, Lingyadh Village Seepat Road Bilaspur (CG)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G048||Other encephalitis, myelitis and encephalomyelitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Sofosbuvir and Ribavirin  Sofosbuvir 150-200 mg OD for 3-6 month Ribavirin 200 mg BD for 6 month  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Children and adult with Subacute Sclerosing Pan Encephalitis 
 
ExclusionCriteria 
Details  Parents not willing to participate in study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality at 18 month  Mortality at 18 month 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement or cessation in clinical deterioration  18 month 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/10/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Subacute Sclerosing Panencephalitis (SSPE) is a slow virus infection caused by the mutant measles virus. Most patients with SSPE have a history of primary measles disease in early childhood below two years. SSPE is a rare and now prevalent only in the Indian subcontinent. An annual incidence of 21 per million populations in India reported in the literature. The disease has orphan status with no substantial advancement in diagnostic or therapeutic modalities. No adequate therapy is currently available for the treatment of SSPE. As a result, the patients suffering from SSPE survive only for 1- 3 years after diagnosis, with a mean survival of about 18 months.

Observations of some non- randomized trials suggest that specific antiviral drugs and immune-modulator agents can prolong life. A combination of intra-ventricular interferon alfa plus oral Isoprinosine / Ribavirin is the best effective treatment available. It is observed that development of C treatment modalities for SSPE and Hepatitis-C. Is similar before development of newer antiviral agents for cure of Hepatitis-C.

 Comparison between SSPE and Hepatitis- C is given in table below

 

SSPE

HEPATITIS- C

Type of virus

RNA

RNA

Latent period before disease manifestation

Prolonged and variable

Prolonged and variable

Treatment

 

 

Alfa interferon

Yes

Yes

Ribavirin

Yes

Yes

Combined treatment  Alfa interferon + Ribavirin

Yes

Yes

Newer drugs

No

Yes

Outcome

Mostly fatal

Curable due to newer antiviral














Ribavirin is an antiviral medication used to treat respiratory syncytial virus infection, hepatitis C and some viral hemorrhagic fevers.  Sofosbuvir recommended treating Hepatitis C in combination with Ribavirin, interferon- alfa, and newer antiviral agent. Common side effects of Sofosbuvir include feeling tired, headache, nausea, and trouble sleeping. Side effects are more common in interferon-containing regimens.

Aim:

1. To evaluate the clinical efficacy of combo treatment of Sofosbuvir and Ribavirin on SSPE patients.

2. To note the impact of combo therapy on the survival of SSPE patients.

Objectives:

 To assess the outcome of SSPE after 3- 6 months of combined treatment with Sofosbuvir and Ribavirin.

 Methodology:

 The study is a non- placebo purely observational and repositioning trial with Ribavirin with Sofosbuvir in the treatment of SSPE. All patients will be treated with standard care with anti-epileptic drugs, amantadine, and oral doses of Ribavirin. Also, they will receive Sofosbuvir according to body weight (150- 200 mg/day) for three months. One minute home video recording of every patient will be analyzed for frequency of myoclonic jerks and overall improvement every three months after induction to treatment, and survival will be recorded at 18 months of all enrolled patients in the study.

 
Close