Analysis of the Glutathione Cycle in Children With Rett S... | NCT02360436

Studies
Analysis of the Glutathione Cycle in Children With Rett Syndrome

NCT02360436

Sponsor

Edison Pharmaceuticals Inc

Status

Withdrawn

Last Update Posted

Feb 3, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Rett Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Priorities other studies

Expanded Access Info

Start Date

Mar 31, 2015Actual

Primary Completion Date

Jul 31, 2015Estimated

Completion Date

Sep 30, 2015Estimated

First Submitted Date

Feb 2, 2015

First Submission Date that Met QC Criteria

Feb 5, 2015

First Posted Date

Feb 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2022

Last Update Posted Date

Feb 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	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		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan Percy, MD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama, Birmingham		Birmingham	Alabama	35233	United States

Label	URL
Edison Pharmaceutical's Website	View source

Condition Browse Module

MeSH Terms

ID	Term
D015518	Rett Syndrome

Ancestor Terms

ID	Term
D038901	X-Linked Intellectual Disability
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided