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Oral Glyceryl Triacetate (GTA) in Newborns With Canavan

NCT00724802 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2011-06-21

No results posted yet for this study

Summary

Canavan disease is caused by Aspartoacylase deficiency. There is no treatment for the disease, but there is a food additive that includes acetate . We suggest an early treatment with acetate and a neurologic evaluation, including MRI, after 4 months of treatment. In any case the treatment will be stopped at the age of 22 months, when myelinization is ended.

Conditions

  • Canavan Disease

Interventions

DIETARY_SUPPLEMENT

GTA (Glyceryl triacetate)

0.5 gr/kg x2/day syrup two times a day with increasing dose each 3 days till max 5gr /kg each day for 6 months

DRUG

GTA glyceryl triacetate

0.5 gr/kg twice a day with increase of 0.5 gr/kg every 3 days up to 5 gr/kg

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Gheona Alterescu, M.D. · Shaare Zedek Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00724802 on ClinicalTrials.gov