Analysis of the Glutathione Cycle in Children With Rett Syndrome

January 20, 2022 updated by: Edison Pharmaceuticals Inc

EPITRA-14-001: Analysis of the Glutathione Cycle in Children With Rett Syndrome

Analyis of the Glutathione Cycle in Children with Rett Syndrome

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama, Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children aged 2-10 with genetically confirmed diagnosis of Rett syndrome with MeCP2 mutation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of changes in levels of glutathione and relevant glutathione metabolites in children with Rett syndrome from baseline to the end of month 6
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alan Percy, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2015

Primary Completion (Anticipated)

July 31, 2015

Study Completion (Anticipated)

September 30, 2015

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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