International Ataxia Rating Scale in Younger Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01942850
• Date of registration: 06/09/2013
• Prospective Registration: No
• Primary sponsor: Erydel
• Public title: International Ataxia Rating Scale in Younger Patients
• Scientific title: APPLICABILITY OF THE INTERNATIONAL ATAXIA RATING SCALE (ICARS) IN YOUNGER PATIENTS AND DEVELOPMENT OF GLOBAL RATING INSTRUMENTS FOR PATIENTS WITH ATAXIA TELANGIECTASIA (AT)
• Date of first enrolment: August 2013
• Target sample size: 63
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01942850
• Study type: Observational
• Study design: Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

India, Israel, Italy, United States

Contacts

• Name: Luca Benatti, MD
• Affiliation: Erydel

Key inclusion & exclusion criteria

Inclusion criteria

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 a-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



Age minimum: 6 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ataxia Telangiectasia

Primary Outcome(s)

Correlation Analysis [Time Frame: single visit]

Secondary ID(s)

ICARS-CGI-Ery01-2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors