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Analysis of the Glutathione Cycle in Children With Rett Syndrome

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Disease Information

Descriptive Information
Brief Title † Analysis of the Glutathione Cycle in Children With Rett Syndrome
Official Title † EPITRA-14-001: Analysis of the Glutathione Cycle in Children With Rett Syndrome
Brief Summary Analyis of the Glutathione Cycle in Children with Rett Syndrome
Detailed Description To analyze the levels of glutathione and relevant glutathione metabolites in children with Rett syndrome in an effort to better understand disease pathology and biochemistry.
Study Phase N/A
Study Type † Observational
Study Design † Observational Model: Case-Only, Time Perspective: Prospective
Primary Outcome Measure † Analysis of changes in levels of glutathione and relevant glutathione metabolites in children with Rett syndrome from baseline to the end of month 6
Secondary Outcome Measure †
Condition † Rett Syndrome
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 20
Start Date † March 2015
Completion Date September 2015
Primary Completion Date July 2015
Eligibility Criteria † Inclusion Criteria: - Age between 2 and 10, inclusive - Genetically-confirmed diagnosis of Rett syndrome with MeCP2 mutation - No change in dietary supplements in three months prior to the initial blood draw - No participation in interventional pharmaceutical clinical trials in prior 12 months Exclusion Criteria: - None other than meeting Inclusion criteria
Gender Both
Ages 2 Years - 10 Years
Accepts Healthy Volunteers No
Contacts †† Matthew B Klein, MD, FACS, 650-641-9211, mklein@edisonpharma.com
Location Countries † United States
Administrative Information
NCT ID † NCT02360436
Organization ID EPITRA-14-001
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Edison Pharmaceuticals Inc
Collaborators ††
Investigators † Principal Investigator: Alan Percy, MD, University of Alabama at Birmingham
Information Provided By
Verification Date February 2015
First Received Date † February 2, 2015
Last Updated Date February 5, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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