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A Study to Evaluate Ketamine for the Treatment of Rett Syndrome

NCT03633058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-05-28

Study results available
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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.

Conditions

Interventions

DRUG

Ketamine

oral ketamine dosed twice daily for 5 days

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Rett Syndrome Research Trust

    lead OTHER

Principal Investigators

  • Jeffrey Neul, MD, PhD · Vanderbilt University Medical Center

  • Jana von Hehn, PhD · Rett Syndrome Research Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2021-11-08
Completion
2021-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633058 on ClinicalTrials.gov