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NCT01520363 · ClinicalTrials.gov registry record · Phase 2

Placebo Controlled Trial of Dextromethorphan in Rett Syndrome

A Phase 2 study of Rett Syndrome, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.

Completed
Registry status
Phase 2
Development phase
57
Enrollment target
1
Study location

NCT01520363 is a Phase 2 study of Rett Syndrome that has completed, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 57 participants, below the 523-participant average among 18 other Rett Syndrome trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01520363, a Phase 2 study of Rett Syndrome, has completed, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.

COMPLETED
Registry status
Phase 2
Development phase
57 participants
Enrollment target
1
Study location

Study 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 Unit (PCRU) of the Johns Hopkins Hospital/Kennedy Krieger Institute. Funding source , FDA-00PD It has been shown that receptors for a certain brain chemical called glutamate, in particular the NMDA type, are increased in the brain of young RTT patients (\<10 years of age). This chemical and its receptors, when in excess, cause harmful over-stimulation of nerve cells in the brain, contributing in part to the seizures, behavioral problems, and learning disabilities in RTT. The investigators propose to initiate a specific treatment using DM to counter/block the effects of this brain chemical and its excessive receptors to improve the ill effects of increased glutamate/NMDA receptors, because of DM's identified ability to block NMDA receptors. DM is available for human consumption. Infants and children with respiratory infections and cough, as well as non-ketotic hyperglycinemia, are treated with DM, which has been well tolerated.

Conditions Studied

Rett Syndrome

Interventions

  • DRUG placebo
  • DRUG dextromethorphan

Study Locations (1)

Maryland

  • The Johns Hopkins Institute for Clinical and Translational Research - Baltimore

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2012-03
Est. Completion 2016-10-26
Phase Phase 2

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger

73 total trials

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What the Registry Record Tells You About NCT01520363

The ClinicalTrials.gov registry entry for NCT01520363 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 523-participant average among 18 other Rett Syndrome trials with a reported enrollment target (89% lower). The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rett Syndrome appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT01520363 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01520363 about?

NCT01520363 is a clinical study titled "Placebo Controlled Trial of Dextromethorphan in Rett Syndrome". 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 Unit (PCRU) of the Johns Hopkins Hospital/Kennedy Krieger Institute. Funding source , FDA-00PD It ...

What is the current status of trial NCT01520363?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2012-03. Estimated completion is 2016-10-26.

What conditions does trial NCT01520363 study?

This clinical trial studies the following conditions: Rett Syndrome.

What interventions are being tested in trial NCT01520363?

The interventions under investigation include: placebo (DRUG), dextromethorphan (DRUG).

Who is sponsoring clinical trial NCT01520363?

This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01520363 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.