| CTRI Number |
CTRI/2013/10/004088 [Registered on: 22/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Validation of rating scales |
| Study Design |
Other |
|
Public Title of Study
|
Validation of International Cooperative Ataxia Rating Assesment Scale in younger age group of patients with ataxia and to develop a rating scale for patients with Ataxia Telangiectasia |
|
Scientific Title of Study
|
Applicability of the International Cooperative Ataxia Rating Scale (ICARS) in younger patients and development of global rating instruments for patients with Ataxia Telangiectasia (AT) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CGI-AT, Ver: 1.0, Date:02 June 2013 |
Protocol Number |
| NCT01942850 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anaita Hegde |
| Designation |
Consultant Pediatric Neurologist |
| Affiliation |
Jaslok Hospital & Research Centre |
| Address |
Jaslok Hospital & Research Centre,
15 - Dr. Deshmukh Marg,
Pedder Road
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9820186155 |
| Fax |
|
| Email |
docanaita@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajat Hazra |
| Designation |
Director, Clinical Operations - India |
| Affiliation |
CliniRx Tangent Research India Pvt Ltd |
| Address |
No. 24, First Floor,
Pandian Street-Shankaren Avenue,
Velachery Bypass Road
Velachery
Chennai
TAMIL NADU
600042
India |
| Phone |
9094783066 |
| Fax |
|
| Email |
rhazra@clinirx.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Hazra |
| Designation |
Director, Clinical Operations - India |
| Affiliation |
CliniRx Tangent Research India Pvt Ltd |
| Address |
No. 24, First Floor,
Pandian Street-Shankaren Avenue,
Velachery Bypass Road
Velachery
Chennai
TAMIL NADU
600042
India |
| Phone |
9094783066 |
| Fax |
|
| Email |
rhazra@clinirx.com |
|
|
Source of Monetary or Material Support
|
| Erydel SPA
URBINO (PU)
Via Sasso 36
61029 - Italy |
|
|
Primary Sponsor
|
| Name |
Erydel SPA |
| Address |
URBINO (PU)
Via Sasso 36
61029 - Italy
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CliniRx Tangent Research |
No. 24, First Floor, Pandian Street-Shankaren Avenue,
Velachery Bypass Road,
Velachery,
Chennai - 600042
India |
|
|
Countries of Recruitment
|
India
Israel
Italy
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vykunt Raju |
Indira Gandhi Institute of Child Health |
India Gandhi Institute of Child Health, Department of Pediatric Neurology, DRC Post, South Hospital complex, Near NIMHANS
Bangalore
KARNATAKA |
9535212556
drknvraju@hotmail.com |
| Dr Anaita Hegde |
Jaslok Hospital |
Jaslok Hospital & Research centre, 9th floor, Pediatric research room, 15 Dr G. Deshmukh Marg, Mahim
Mumbai
MAHARASHTRA |
9820186155
docanaita@rediffmail.com |
| Dr Rupam Borghain |
Nizam’s Institute of Medical Science |
Nizam’s Institute of Medical Science,Department Of Neurology
Punjagutta
Hyderabad
ANDHRA PRADESH |
9866191476
b_rupam@hotmail.com |
| Dr Vrajesh Udani |
PD Hinduja Healthcare |
PD Hinduja Healthcare National Health and Medical research Centre, Department of Pediatric Neurology, Veer Savarkar Marg, Mahim
Mumbai
MAHARASHTRA |
9819596661
vrajeshudani@yahoo.co.in |
| Dr Sangeeta H Ravat |
Seth G. S. Medical College & KEM Hospital, |
Seth G. S. Medical College & KEM Hospital,
Department of Neurology,
Acharya Donde Marg,Parel,
Mumbai - 400012
Mumbai
MAHARASHTRA |
9820310850
ravatsh@yahoo.com |
| Dr A S Keerthi |
SVRR Government General Hospital |
SVRR Government General Hospital,
Department of Pediatrics,
Near Alipiri
Tirupati
Chittoor
ANDHRA PRADESH |
9642596765
somakeerthi@yahoo.co.in |
| Dr Suresh Kumar |
Vijaya Health Centre |
Vijaya Health Centre
neuro Lab & Neuro Clinic, Room no 1 & 2, OPD Block, 175 NSK Salai, Vadapalani
Chennai
TAMIL NADU |
9841183019
doc_suresh@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) II, Seth G. S. Medical College & K.E.M. Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Indira Gandhi Institute of Child Health |
Not Applicable |
| Institutional Ethics Committee, SV Medical College |
Not Applicable |
| Institutional ethics Committee, Vijaya Health Centre |
Approved |
| Jaslok Hospital & Research Center Ethics Committee |
Approved |
| National Health and Education Society |
Not Applicable |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Ataxia (including Ataxia Telangiectasia), |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 6-18 years with diagnosed with ataxia, preferably AT will be included. The diagnosis of AT will be made based on the criteria: typical clinical picture plus one of the following: 1. a proven mutation in the ATM gene 2. Deficient ATM protein proven by Western blotting 3. Elevated α-fetoprotein, cerebellar atrophy on MRI and immune deficiency/ chromosomal breakage/ T- cell lymphoreticular malignancy.
2. Children aged 6-18 years with suspected AT (fulfilling partially the above criteria will be included)
3. Children aged 6-18 years with AT like disease, with or without proven mutation in the MRE11 gene will be included
4. Children aged 6-18 years of age with ataxia of other known or unknown etiologies might be included, but their total number should not exceed 20% of the cohort in each site |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validity & reliability of ICARS in young age group of Ataxia & Ataxia Telangiectasia patients |
None |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total scores comparison in the ages 6-10 and 10-18 years.
2. Correlation of ICARS scores with Clinical Global Impression of Severity (CGI-S) of the disease.
3. The Scale for the Assessment and Rating of Ataxia (SARA) by Clinical Global Impression of Severity (CGI-S)
4. The Brief Ataxia Rating Scale (BARS) by Clinical Global Impression of Severity (CGI-S) |
None |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="40"
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)
|
21/10/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/09/2013 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ataxia Telangiectasia (AT) is a severe neurologic disorder with progressive loss of walking capacity, ultimately leading to wheel chair. There is no curative treatment for AT, but some several attempts were made to use different drugs for improving neurologic symptoms. However, all attempts to check the benefit of any drug treatment is hindered by the lack of rating scale that measures the degree of neurologic disease in children with AT. The goal of our study is to validate the ICARS scale, in order to be further used in interventional studies with drugs treatments that might improve neurologic symptoms. |