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Home > "S" Clinical Trials Conditions > Study of the Pathogenesis of Rett Syndrome  Study of the Pathogenesis of Rett Syndrome
Study of the Pathogenesis of Rett Syndrome
For Condition: Rett Syndrome
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , Johns Hopkins University
Synopsis: OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome (RS). II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning. IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /45 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: Rett syndrome Diagnosis confirmed on study
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
SakkubaiNaidu, Study Chair, Johns Hopkins University
Additional Information:
Study ID Numbers: 199/12009; JHUSM-KKI-87021203
Study Start Date: January 1995
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004807
Other Rett Syndrome Studies:
1. Dextromethorphan and Donepezil Hydrochloride for Rett Syndrome
2. Study of the Pathogenesis of Rett Syndrome
3. Nutritional Aspects of Rett Syndrome
4. Study of Cardiac and Paroxysmal Abnormalities in Rett Syndrome
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Other Rett Syndrome Clinical Trials
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Study of the Pathogenesis of Rett Syndrome
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