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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00069550
Date of registration:	29/09/2003
Prospective Registration:	Yes
Primary sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Public title:	Independent Studies of Dextromethorphan and of Donepezil Hydrochloride for Rett Syndrome
Scientific title:	Pathogenesis of Rett Syndrome: Natural History and Treatment
Date of first enrolment:	September 2004
Target sample size:	90
Recruitment status:	Recruiting
URL:	http://clinicaltrials.gov/show/NCT00069550
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	Phase 3

Countries of recruitment
United States

Contacts

Name:	SakkuBai R. Naidu, MD
Address:
Telephone:	443-923-2778
Email:
Affiliation:

Name:	SakkuBai R. Naidu, MD
Address:
Telephone:
Email:
Affiliation:	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Name:	SakkuBai R. Naidu, MD
Address:
Telephone:	443-923-2778
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum: 1 Year
Age maximum: 15 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rett Syndrome

Intervention(s)

Drug: dextromethorphan

Drug: donepezil hydrochloride

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

5 PO1 HD024448

HD024448

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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