Rett SyndromeNCT02360436
Analysis of the Glutathione Cycle in Children With Rett Syndrome
An observational study of Rett Syndrome, run by Edison Pharmaceuticals Inc at 1 site in United States.
Trial summary
Analyis of the Glutathione Cycle in Children with Rett Syndrome Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Rett Syndrome
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2015to 30 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 2-10 with genetically confirmed diagnosis of Rett syndrome with MeCP2 mutation
Who may be able to join
- 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
Who cannot join
- None other than meeting Inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama, Birmingham
Birmingham, Alabama, 35233
About this study
Official title: EPITRA-14-001: Analysis of the Glutathione Cycle in Children With Rett Syndrome
Analyis of the Glutathione Cycle in Children with Rett Syndrome
Read the 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.
- Conditions
- Rett Syndrome
- Keywords
- Rett, MeCP2, Glutathione, Cysteine, ROS
- Medical subject headings
- Rett Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of changes in levels of glutathione and relevant glutathione metabolites in children with Rett syndrome from baseline to the end of month 6
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start31 Mar 2015
- Primary completion31 Jul 2015 (estimated)
- Study completion30 Sep 2015 (estimated)
Why it stopped: Priorities other studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rett SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edison Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Percy, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360436
- Sponsor's protocol ID
- EPITRA-14-001
- Status last verified
- Jan 2022
- First submitted
- 2 Feb 2015
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPITRA-14-001: Analysis of the Glutathione Cycle in Children With Rett Syndrome
- ClinicalTrials.gov ID
- NCT02360436
- Acronym / sponsor ID
- EPITRA-14-001
- Conditions
- Rett Syndrome
- Keywords
- Rett, MeCP2, Glutathione, Cysteine, ROS
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Priorities other studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Edison Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2015 (actual)
- Primary completion
- 31 Jul 2015 (estimated)
- Study completion
- 30 Sep 2015 (estimated)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 2-10 with genetically confirmed diagnosis of Rett syndrome with MeCP2 mutation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None other than meeting Inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Percy, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rett Syndrome, run by Edison Pharmaceuticals Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.