MedPath

Effects of nicotinamide riboside (vitamin B3) in patients with Ataxia Telangiectasia

Phase 2
Completed
Conditions
A-T
Louis Bar syndrome
10021460
10028037
10024967
Registration Number
NL-OMON48100
Lead Sponsor
Radboud Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
25
Inclusion Criteria

-A-T patients who visit our outpatient clinic
-Genetically confirmed diagnosis of A-T by the identification of pathogenic mutations of the ATM gene.
-Age * 2 years or older and bodyweight * 12 Kg
-Informed consent

Exclusion Criteria

-Additional medical condition or illness that impair the patient*s ability to participate in the study (e.g. actual treatment of a malignancy, active infection, poorly controlled diabetes mellitus, hypertension, organ failure, clinically significant hematological or biochemical abnormalities different from the usual abnormalities in A-T)
-Elevated serum transaminases (> 2 times upper limit of normal)
-Participation in another interventional study at start of the study or during the study
-pregnancy/ breastfeeding

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary Objective:<br /><br>To assess changes in motor performance (ataxia and dysarthria) during the<br /><br>treatment period with NR.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary objectives:<br /><br>- To assess any changes in quality of life of A-T patients during the treatment<br /><br>period with NR.<br /><br>If changes occur in primary objectives (ataxia or dysarthria), it is<br /><br>conceivable that this affects<br /><br>quality of life.<br /><br>- To assess any changes in laboratory parameters that are known to be abnormal<br /><br>in most patients with A-T during the treatment period with NR. These values are<br /><br>an objective measurement to investigate the effect of NR in patients with A-T. </p><br>
© Copyright 2025. All Rights Reserved by MedPath