Antioxidant cocktail may ease motor deficits in rett syndrome — a trial investigates
NCT ID NCT04041713
First seen Jul 27, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This pilot study tests whether an antioxidant cocktail called Rett-T can improve motor function in children and adolescents with Rett syndrome, a rare genetic disorder that affects movement and coordination. Participants, aged 2 to 21 and at least partially able to walk, will receive either Rett-T or a placebo. The trial measures changes in motor skills and explores biological markers of safety and response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an antioxidant cocktail called Rett-T
- What this could lead to
- If effective, this antioxidant cocktail could offer a new way to ease motor difficulties in Rett syndrome, potentially improving daily function.
- What could go wrong
- This is a small early-stage pilot study, so results may not be conclusive. Antioxidants can interact with other medications, and benefits may be modest or absent.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 21 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Holland Bloorview Kids Rehabilitation Hospital
RECRUITINGToronto, Ontario, M4G 1R8, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Low-THC cannabis extract tested against rett syndrome symptoms
- A private facebook group may ease the emotional burden of caring for a child with rett syndrome
- Can robot legs help Non-Walking kids join in at school?
- Can early parent coaching help infants with rare genetic disorders thrive?
- Newborn screening study aims to catch rare diseases at birth
- Massive global registry aims to unlock secrets of rett syndrome