|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
8 April 2024 |
|
Main ID: |
NCT03633058 |
|
Date of registration:
|
08/08/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Study to Evaluate Ketamine for the Treatment of Rett Syndrome
|
|
Scientific title:
|
A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Assess the Safety, Tolerability and Efficacy of Oral Ketamine for Patients With Rett Syndrome |
|
Date of first enrolment:
|
March 12, 2019 |
|
Target sample size:
|
23 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03633058 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Jana von Hehn, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Rett Syndrome Research Trust |
|
|
Name:
|
Jeffrey Neul, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Vanderbilt University Medical Center |
| |
|
Key inclusion & exclusion 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.
Age minimum:
6 Years
Age maximum:
12 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Rett Syndrome
|
|
Intervention(s)
|
|
Drug: Ketamine
|
|
Primary Outcome(s)
|
|
Dose-Limiting Adverse Events
[Time Frame: 6 weeks]
|
|
Secondary ID(s)
|
|
Ket-101-RSRT
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|