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Rett T for Rett Syndrome

Phase 2
Waitlist Available
Led By Evdokia Anagnostou, MD
Research Sponsored by Anagnostou, Evdokia, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks total: 8 weeks on rett-t, 8 weeks on placebo, 2 week washout in interim
Awards & highlights

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.

Eligible Conditions
  • Rett Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks total: 8 weeks on rett-t, 8 weeks on placebo, 2 week washout in interim
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks total: 8 weeks on rett-t, 8 weeks on placebo, 2 week washout in interim for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rett Syndrome Natural History Motor Behavior Assessment (MBA)
Secondary outcome measures
Anxiety, Depression, and Mood Scale (ADAMS)
Children's Sleep Habits Questionnaire (CSHQ)
Clinical Global Impressions - Improvement Scale - Global (CGI-I)
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Rett TActive Control1 Intervention
Rett T is a powder for oral suspension. Dosage is dependent on weight. For participants weighing <30 kg, a 4 g dose (i.e., one 4 g sachet) is intended to be administered orally once a day after dissolving in approximately 125 mL of water. For participants weighing ≥30 kg, a 8 g dose (i.e., two 4 g sachets) is intended to be administered orally once a day after dissolving in approximately 250 mL of water.
Group II: PlaceboPlacebo Group1 Intervention
Placebo is a powder for oral suspension. Dosage is dependent on weight. For participants weighing <30 kg, a 4 g dose (i.e., one 4 g sachet) is intended to be administered orally once a day after dissolving in approximately 125 mL of water. For participants weighing ≥30 kg, a 8 g dose (i.e., two 4 g sachets) is intended to be administered orally once a day after dissolving in approximately 250 mL of water.

Find a Location

Who is running the clinical trial?

Unity Health TorontoOTHER
536 Previous Clinical Trials
447,494 Total Patients Enrolled
Holland Bloorview Kids Rehabilitation HospitalOTHER
67 Previous Clinical Trials
14,039 Total Patients Enrolled
Anagnostou, Evdokia, M.D.Lead Sponsor
2 Previous Clinical Trials
146 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Pilot Study of an Antioxidant Cocktail vs. Placebo in the Treatment of Children and Adolescents With Rett Syndrome
2019. "A Pilot Study of an Antioxidant Cocktail vs. Placebo in the Treatment of Children and Adolescents With Rett Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04041713.
All > Rett Syndrome
~6 spots leftby Apr 2025
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