Status:
COMPLETED
Placebo Controlled Trial of Dextromethorphan in Rett Syndrome
Lead Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborating Sponsors:
The Johns Hopkins Institute for Clinical and Translational Research (ICTR)
Conditions:
Rett Syndrome
Eligibility:
All Genders
1-10 years
Phase:
PHASE2
Brief Summary
Dr. Sakkubai Naidu, Principal Investigator, is initiating a double blinded placebo controlled clinical drug trial using dextromethorphan (DM) in Rett Syndrome (RTT), at the Pediatric Clinical Research...
Detailed Description
The study will last for 3 months and will be limited to MECP2 mutation-positive children, one year - 9.99 years of age. This clinical trial, which is a placebo-controlled study, will randomize patient...
Eligibility Criteria
Inclusion
- males and females who have classic or atypical RTT with a proven mutation in the MECP2 gene;
- subjects must be between one year - 10 years of age.
Exclusion
- those without an established mutation in the MECP2 gene;
- those with mutations in the MECP2 gene but who have had brain resection or surgical intervention; for example, tumor, hydrocephalus, severe head trauma; or, an associated severe medical illnesses such as vasculopathies, malignancies, diabetes, thyroid dysfunction, etc;
- those on medications that could interact with DM, e.g. MAO inhibitors, SSRI, sibutramine etc. to avoid a serotonin syndrome; quinidine and drugs metabolized by the CYP450 isoform CYP2D6 (e.g. amiodarone, haloperidol, propafenone, thioridazine);
- those proven to be intermediate or slow metabolizers of DM;
- those with reported adverse reactions to DM;
- those whose pregnancy test is positive;
- those showing poor compliance with any aspect of the study;
- foster children.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2016
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01520363
Start Date
March 1 2012
End Date
October 26 2016
Last Update
December 4 2018
Active Locations (1)
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1
The Johns Hopkins Institute for Clinical and Translational Research
Baltimore, Maryland, United States, 21287