Recruiting
Phase 3

Dextromethorphan & Donepezil

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00069550

Conditions

Rett Syndrome

Eligibility Criteria

Sex: All

Age: 1 - 15

Healthy Volunteers: Not accepted

Interventions

dextromethorphan

donepezil hydrochloride

Study Details

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.

Conditions

Rett Syndrome

Study ID

NCT00069550

Start date

Sep, 2004

Status verified date

Dec, 2004

Completion date

Jun, 2008

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 15

Healthy Volunteers: Not accepted

Inclusion Criteria

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

Exclusion Criteria

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

Study Design

Enrollment

90 participants

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

dextromethorphan

donepezil hydrochloride

Central Contacts and Locations

Central contacts

SakkuBai R. Naidu, MD

443-923-2778

Barbara Ann Bradford

443-923-2778bradford@kennedykrieger.org

Locations

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States

Contacts

SakkuBai R. Naidu, MD

443-923-2778

Genila Bibat, MD

443-923-2778bibat@kennedykrieger.org

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Jun 24, 2005

Last verified

Dec, 2004

Keywords

  • Glutamate/NMDA receptors
  • Cholinergic upregulation
  • Dextromethorphan
  • Donepezil hydrochloride
  • Aricept

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2005-06-24.