Oral Glyceryl Triacetate (GTA) in Newborns With Canavan
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ClinicalTrials.gov Identifier: NCT00724802 |
Recruitment Status : Unknown
Verified June 2011 by Shaare Zedek Medical Center.
Recruitment status was: Recruiting
First Posted : July 30, 2008
Last Update Posted : June 21, 2011
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Sponsor:
Shaare Zedek Medical Center
Information provided by:
Shaare Zedek Medical Center
Tracking Information | ||||
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First Submitted Date ICMJE | June 18, 2008 | |||
First Posted Date ICMJE | July 30, 2008 | |||
Last Update Posted Date | June 21, 2011 | |||
Study Start Date ICMJE | March 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
brain MRI at the end of the study [ Time Frame: 6 months ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Oral Glyceryl Triacetate (GTA) in Newborns With Canavan | |||
Official Title ICMJE | Oral Glyceryl Triacetate (GTA) in Newborns With Canavan | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Canavan Disease | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Segel R, Anikster Y, Zevin S, Steinberg A, Gahl WA, Fisher D, Staretz-Chacham O, Zimran A, Altarescu G. A safety trial of high dose glyceryl triacetate for Canavan disease. Mol Genet Metab. 2011 Jul;103(3):203-6. doi: 10.1016/j.ymgme.2011.03.012. Epub 2011 Mar 15. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
1 | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | up to 18 Months (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Israel | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00724802 | |||
Other Study ID Numbers ICMJE | canavangta | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Dr. Gheona Alteresco, Shaare Zedek Medical Center | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Shaare Zedek Medical Center | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Shaare Zedek Medical Center | |||
Verification Date | June 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |