| 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
|
|
|
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
|
|
|
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. |