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NCT03633058 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Ketamine for the Treatment of Rett Syndrome
A Phase 2 study, sponsored by Rett Syndrome Research Trust.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT03633058: Completed Phase 2 study, sponsored by Rett Syndrome Research Trust.
NCT03633058 is a Phase 2 study that has completed, run by Rett Syndrome Research Trust. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03633058, a Phase 2 study, has completed, sponsored by Rett Syndrome Research Trust.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study 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.
Primary Outcome
The Number of Participants with Treatment-emergent adverse events on ketamine compared to placebo will be summarized
Interventions
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2021-11-22 |
| Phase | Phase 2 |
What the finished NCT03633058 record still lists
NCT03633058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Ketamine is the first listed.
NCT03633058 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03633058 about?
NCT03633058 is a clinical study titled "A Study to Evaluate Ketamine for the Treatment of Rett Syndrome". 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 partici...
What is the current status of trial NCT03633058?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2019-03-12. Estimated completion is 2021-11-22.
What interventions are being tested in trial NCT03633058?
The interventions under investigation include: Ketamine (DRUG).
Who is sponsoring clinical trial NCT03633058?
This trial is sponsored by Rett Syndrome Research Trust, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03633058's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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