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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: Completed Phase 2 study of Rett Syndrome, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Mullen Scales of Early Learning (MULLEN) Visual reception subscale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Conditions Studied
Interventions
- DRUG placebo
- DRUG dextromethorphan
Study Locations (1)
Maryland
- The Johns Hopkins Institute for Clinical and Translational Research - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-10-26 |
| Phase | Phase 2 |
What the finished NCT01520363 record still lists
NCT01520363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 523-participant average among 18 other Rett Syndrome trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01520363's enrollment target sits among peer trials
57 9th of 18 higher than 10 of 18 other Rett Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rett Syndrome 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.
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