NCT00069550

Brief Summary

Rett syndrome (RTT) is a disorder in which the nervous system does not develop properly. RTT generally affects girls, but there are some boys who have been diagnosed with RTT. Symptoms of RTT include small brain size, poor language skills, repetitive hand movements, and seizures. This study will evaluate the effectiveness of two drugs in treating the symptoms of RTT.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2003

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2004

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2004

First QC Date

September 29, 2003

Last Update Submit

June 23, 2005

Conditions

Rett Syndrome

Keywords

Glutamate/NMDA receptorsCholinergic upregulationDextromethorphanDonepezil hydrochlorideAricept

Interventions

dextromethorphanDRUG
donepezil hydrochlorideDRUG

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of Rett syndrome
  • Mutation in MeCP2 gene
  • Typical EEG abnormalities (disorganized background, frontal central spikes, rhythmic theta)

You may not qualify if:

  • Features of Rett syndrome with absence of MeCP2 mutation
  • Non-specific EEG changes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, United States

RECRUITING

MeSH Terms

Conditions

Rett Syndrome

Interventions

DextromethorphanDonepezil

Condition Hierarchy (Ancestors)

X-Linked Intellectual DisabilityIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeredodegenerative Disorders, Nervous System

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsIndansIndenesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • SakkuBai R. Naidu, MD

    Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SakkuBai R. Naidu, MD

CONTACT

443-923-2778

Barbara Ann Bradford

CONTACT

443-923-2778bradford@kennedykrieger.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 29, 2003

First Posted

September 30, 2003

Study Start

September 1, 2004

Study Completion

June 1, 2008

Last Updated

June 24, 2005

Record last verified: 2004-12

Locations

US(1)