Oral Glyceryl Triacetate (GTA) in Newborns With Canavan
Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00724802
Collaborator
(none)
1
1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Oral Glyceryl Triacetate (GTA) in Newborns With Canavan
Study Start Date
:
Mar 1, 2008
Actual Primary Completion Date
:
Aug 1, 2008
Outcome Measures
Primary Outcome Measures
- brain MRI at the end of the study [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 18 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- clinical diagnosis of Canavan disease
Exclusion Criteria:
- Age above 18 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shaare Zedek Medical Center | Jerusalem | Israel | 91031 |
Sponsors and Collaborators
- Shaare Zedek Medical Center
Investigators
- Principal Investigator: Gheona Alterescu, M.D., Shaare Zedek Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00724802
Other Study ID Numbers:
- canavangta
First Posted:
Jul 30, 2008
Last Update Posted:
Jun 21, 2011
Last Verified:
Jun 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms: