Central randomized, double-blind, crossover, multicenter clinical trial of Betametasone and placebo in children with ataxia teleangectasia - FMPS?30094

• Conditions: ataxia teleangectasia; MedDRA version: 9.1Level: SOCClassification code 10029205Term: Nervous system disorders

• Registration Number: EUCTR2008-001185-91-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

INCLUSION CRITERIA 1) proven molecular diagnosis of A-T (AFP level more than twice the upper limit of normal and demonstration of ATM protein deficiency by Western blot); 2) evident neurological signs of ataxia (uncoordination of head and eyes in lateral gaze deflection, gait ataxia associated with an inappropriately narrow base); 3) age between 3; 4) plasma CD4+ lymphocytes/mm3 >= 500 (3-6 years) or >= 200 (> 6 years); 5) written informed consent to participate from the parents and verbal consent to participate from the patient, if able to understand the main concepts and aims of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) confinement to a wheelchair (i.e. inability to walk),
2) current or previous neoplastic disease,
3) history of severe impairment of the immunological system (i.e. history of serious infectious disease),
4) presence of other chronic conditions (i.e. diabetes, mental delay, osteoporosis, etc) representing a contraindication to the use of a steroid drug
5) noncompliance with the aims and methods of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified