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NCT00593957 · ClinicalTrials.gov registry record · Phase 2

Trial of Dextromethorphan in Rett Syndrome

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

Terminated
Registry status
Phase 2
Development phase
38
Enrollment target

NCT00593957: Clinical Trial Phase 2 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.

NCT00593957 is a Phase 2 study that was terminated before completion, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00593957, a Phase 2 study, was terminated before completion, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.

TERMINATED
Registry status
Phase 2
Development phase
38 participants
Enrollment target

Study Summary

Increased brain glutamate and its N-methyl-D-aspartate (NMDA) receptors found in the brain of younger Rett syndrome (RTT) patients cause toxic damage to neurons (the brain's nerve cells), and contributing to EEG spikes. Dextromethorphan (DM) acts by blocking NMDA/glutamate receptors. This study is being done to determine if DM will prevent the harmful over-stimulation of the neurons thereby reducing EEG spike activity. Treatment with DM consists of one of 3 different doses (0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day), and aims to find out which dose if any will help improve EEG abnormalities, behavior, cognition, and reduce seizures, as well as improve breathing abnormalities, motor capabilities, bone density, and GI dysfunction. The study will include 90 females and males with RTT, 2 years-14.99 years of age, with a mutation in the methyl CpG binding protein 2 (MECP2) gene, and spikes on EEG, with or without clinical seizures.

Primary Outcome

Difference in EEG spike count means pre and 6 months post-treatment in each of three treatment groups.

Interventions

  • DRUG Dextromethorphan

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2004-08
Est. Completion 2010-06
Phase Phase 2

Why NCT00593957 stopped before completion

NCT00593957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 1 intervention - of which Dextromethorphan is the first listed.

NCT00593957 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00593957 about?

NCT00593957 is a clinical study titled "Trial of Dextromethorphan in Rett Syndrome". Increased brain glutamate and its N-methyl-D-aspartate (NMDA) receptors found in the brain of younger Rett syndrome (RTT) patients cause toxic damage to neurons (the brain's nerve cells), and contributing to EEG spikes. Dextromethorphan (DM) acts by blocking NMDA/glutamate receptors. This study is b...

What is the current status of trial NCT00593957?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2004-08. Estimated completion is 2010-06.

What interventions are being tested in trial NCT00593957?

The interventions under investigation include: Dextromethorphan (DRUG).

Who is sponsoring clinical trial NCT00593957?

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

How this trial's enrollment target compares

Where NCT00593957's enrollment target sits among peer trials

38 1467th of 2000 higher than 517 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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Source: ClinicalTrials.gov NCT00593957, the US trial registry maintained by the National Library of Medicine. NCT00593957 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.