Completed

Comprehensive Clinical Evaluation for Rett Syndrome Management

Study Aim

This study aims to provide a comprehensive evaluation of treatment strategies for individuals living with Rett Syndrome, focusing on improving their overall health and quality of life.

What is being tested

dextromethorphan

+ topiramate

+ Donepezil

Drug

Who is being recruted

Intellectual Disability+13

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

+ Nervous System Diseases

Until 45 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: January 1995

See protocol details

Summary

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

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1995

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: Patients receive a comprehensive clinical evaluation including an ophthalmologic exam; speech, communication, and developmental assessment; nutritional evaluation; neurologic exam; respiratory monitoring; and cytogenetic studies. Selected patients with malnutrition are given night feedings of Pediasure with Fiber by nasogastric tube. Specific recommendations for feeding techniques and diet are made. Selected patients with seizures or severe hyperventilation and progressive rigidity are nonrandomly assigned to dextromethorphan or topiramate therapy. Oral dextromethorphan is maintained 6 months to 1 year; duration of therapy depends on response. Oral topiramate is given for 6 months to 1 year, and Aricept for 6 months to 1 year. Concurrent anticonvulsants may require dose adjustments while on above protocols. Supportive care for constipation, scoliosis, and weight loss is allowed.

NCT00004807

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

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Intellectual DisabilityCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsHeredodegenerative Disorders, Nervous SystemDisease AttributesGenetic Diseases, InbornX-Linked Intellectual DisabilityGenetic Diseases, X-LinkedMental DisordersNeurologic ManifestationsRett SyndromeRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: Rett syndrome Diagnosis confirmed on study

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers