CompletedPhase 2ketamine
A Study to Evaluate Ketamine for the Treatment of Rett Syndrome
Sponsored by Rett Syndrome Research Trust
NCT ID
NCT03633058
Target Enrollment
23 participants
Start Date
2019-03-12
Est. Completion
2021-11-22
About This Study
This 2 cohort, sequential, ascending dose study will assess the safety, tolerability and efficacy of oral ketamine dosed in a single 5-day BID regimen in addition to placebo, in a 4-week cross-over design in patients with Rett Syndrome. Approximately 12 patients per cohort are anticipated to participate for approximately 8-10 weeks at approximately 7 US study centers.
Conditions Studied
Interventions
- •Ketamine
Eligibility
Sex:FEMALE
Age:6 Years - 12 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Female Rett Syndrome patients diagnosed with Rett Syndrome with a confirmed MECP2 mutation * between the ages of 6 and 12, inclusive, who have not achieved menarche * ability to take oral medications * are generally healthy. Exclusion Criteria: * Patients not on stable medication regimens/other types of behavioral, educational, or dietary interventions for at least 4 weeks, * are taking medications that may interact with ketamine, * have a condition where increased blood pressure, spinal fluid pressure, or ocular pressure may put the patient at increased risk.
Study Locations (7)
University of Alabama Birmingham School of Medicine
Birmingham, Alabama, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Rush University Medical Center
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States