Analysis of the Glutathione Cycle in Children With Rett Syndrome

Sponsor

Edison Pharmaceuticals Inc (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02360436

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Analyis of the Glutathione Cycle in Children with Rett Syndrome

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 31, 2015

Anticipated Primary Completion Date :

Jul 31, 2015

Anticipated Study Completion Date :

Sep 30, 2015

Outcome Measures

Primary Outcome Measures

Analysis of changes in levels of glutathione and relevant glutathione metabolites in children with Rett syndrome from baseline to the end of month 6 [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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