At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 enrolled
Drug / intervention
Ketaminedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Assess the Safety, Tolerability and Efficacy of Oral Ketamine for Patients With Rett Syndrome
In Brief
A Phase 2 clinical trial evaluating Ketamine for Rett Syndrome. Completed, enrolled 23 participants across 7 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRett Syndrome
CountriesUnited States
CollaboratorsVanderbilt University Medical Center
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartMar 2019
Primary CompletionNov 2021
Study CompletionNov 2021
TodayJul 2026
First PostedAug 16, 2018
Enrollment StartMar 12, 2019
Primary CompletionNov 8, 2021
Study CompletionNov 22, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.9 years ago
Interventions
Ketaminedrug
oral ketamine dosed twice daily for 5 days