NCT02360436

Brief Summary

Analyis of the Glutathione Cycle in Children with Rett Syndrome

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

February 2, 2015

Last Update Submit

January 20, 2022

Conditions

Rett Syndrome

Keywords

RettMeCP2GlutathioneCysteineROS

Outcome Measures

Primary Outcomes (1)

  • 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

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Links

MeSH Terms

Conditions

Rett Syndrome

Condition Hierarchy (Ancestors)

X-Linked Intellectual DisabilityIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeredodegenerative Disorders, Nervous System

Study Officials

  • Alan Percy, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 10, 2015

Study Start

March 31, 2015

Primary Completion

July 31, 2015

Study Completion

September 30, 2015

Last Updated

February 3, 2022

Record last verified: 2022-01

Locations

US(1)