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Antioxidant cocktail may ease motor deficits in rett syndrome — a trial investigates

NCT ID NCT04041713

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

2 to 21 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Holland Bloorview Kids Rehabilitation Hospital

    RECRUITING

    Toronto, Ontario, M4G 1R8, Canada

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