Clinical Research Directory

Inclusion Criteria: 1. Females aged 4-25 years of age 2. Weight ≥12 kg 3. Classical/typical RTT as confirmed with a documented pathogenic variant in the MECP2 gene 4. At least 6 months post-regression at screening (i.e. no loss or degradation in ambulation, hand function, speech, non-verbal communication, or social skills within 6 months of screening) 5. Rett Syndrome Clinical Severity Scale rating of 10-36 6. Clinical Global Impression - Severity of Illness score ≥4 7. Stable pattern of seizures or has had no seizures within 8 weeks of screening, as determined by the participant's primary physician 8. Other patient medications must be stable (i.e. no dose adjustments) for at least 8 weeks prior to screening, including steroids, anti-inflammatories, anxiolytics etc Exclusion Criteria: 1. Current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, type 1 diabetes, or uncontrolled type 2 diabetes), renal, hepatic, respiratory, or gastrointestinal disease (such as coeliac disease or inflammatory bowel disease), or major surgery planned 2. Known history or symptoms of long QT syndrome 3. QTcF interval \>450 milliseconds, history of risk factor for torsades de pointes or clinically significant QT prolongation deemed to increase risk 4. Currently receiving treatment with DAYBUE™ (Trofinetide) 5. Currently using other unregistered drugs for the treatment of Rett syndrome, such as Anavex® 6. Currently using or has used recreational or medicinal cannabis or cannabinoid-based medications, including Sativex® or Epidiolex®, within the 12 weeks prior to screening and is unwilling to abstain for the duration of the trial 7. A known or suspected hypersensitivity to cannabinoids or any of the excipients 8. Moderate-severe impairment in hepatic function at screening, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x upper limit of normal (ULN), or total bilirubin (TBL) \> 2 x ULN. This criterion can only be confirmed once laboratory results are available, participants enrolled into the trial who are later found to meet this criterion will be screen-failed. 9. Participant is enrolled in another clinical trial within 14 days of screening or becomes enrolled in another clinical trial throughout the duration of this study 10. Infection and/or antibiotic use in the 2 weeks prior to screening (participants can be recruited following 2 weeks without infection and/or antibiotic use)