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Clinical Trials in Canada / NCT04041713
Recruiting Phase 2

A Pilot Study of an Antioxidant Cocktail vs. Placebo in the Treatment of Children and Adolescents With Rett Syndrome

NCT04041713 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2026-08-24
Last updated
2026-09-02

Condition(s) studied

Rett Syndrome

Investigational drug(s) / intervention(s)

Rett-TPlacebo

Rett-T: antioxidant cocktail

Placebo: Placebo

Study summary

This study will examine the potential efficacy and safety of Rett-T for core motor deficits of Rett syndrome, and will explore biological markers of safety and treatment response.

Eligibility

Sex
FEMALE
Min age
2 Years
Max age
21 Years
Healthy volunteers
No
Inclusion Criteria: 1. Female outpatients 2-21 years of age inclusive. 2. Diagnosis of Rett syndrome. 3. At least partially ambulatory (may need assistive device to take a step). 4. If already receiving stable interventions must meet the following criteria: * If already receiving stable concomitant medications or nutraceuticals affecting behaviour, must be on a stable dose during the preceding 1 month prior to Screening (with the exception of fluoxetine, where a period of 6 weeks is needed), and will not electively initiate new or modify ongoing medications for study duration. 5. Have normal laboratory test results at Screening/Baseline. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator. 6. Ability to complete assessments, fluency in English (parent/legal guardian; participant, if verbal). 7. Ability to obtain assent (if developmentally appropriate), as well as written informed consent from their parent(s)/legal guardian(s). Exclusion Criteria: 1. Pregnant females; sexually active females on inadequate birth control (extremely unlikely in this population). 2. Have another serious medical condition that, based on Investigator judgment, might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Have evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease, not including mild common pediatric diseases in these areas that are stable (e.g. mild asthma, constipation, etc.). 3. Have hypersensitivity to any components of Rett-T. 4. Have one or more of the following: HIV, HBV, HCV, hemophilia (bleeding problems, recent nose and brain injuries), drug abuse, immunity disorder, major depressive episode or psychosis. 5. Unable to tolerate venipuncture procedures for blood sampling. 6. Receiving concomitant medications/nutraceuticals that include any of the components of Rett-T. 7. Actively enrolled in another intervention study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Holland Bloorview Kids Rehabilitation Hospital Toronto Ontario Recruiting

More Holland Bloorview Kids Rehabilitation Hospital trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04041713 on ClinicalTrials.gov ↗ ← All trials in Canada