Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)
|ClinicalTrials.gov Identifier: NCT00147394|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : October 29, 2012
|Condition or disease||Intervention/treatment||Phase|
|Child Development Disorders, Pervasive||Drug: Risperidone||Phase 1|
Pervasive Developmental Disorders is a category of disorders that includes autism and related conditions. While these disorders are rare, they represent a significant public health problem because they are extremely debilitating and lack efficacious therapies. Neuroleptic use in PDD is high and the population appears to be at increased risk of serious sequelae including tardive dyskinesia. Newer atypical neuroleptics including risperidone are now used in 87% of cases but dosing, safety and efficacy is undetermined in the vulnerable population.
This study consists of a total of 3 visits, the initial screening visit where consent, medical history, demographics and vitals will be recorded. Two additional visits with blood sampling will occur. The second visit will be no greater than 30 days from the screening visit and the 3rd visit will be one month from Visit 2.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder|
|Study Start Date :||December 2001|
|Study Completion Date :||June 2004|
- Quantify the variability of clearance and volume of distribution among AE rating, weight gain and ABC responder status.
- Exploratory analysis will be performed to examine the relationship of other factors to risperidone and metabolite concentrations for PK/PD assessment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147394
|United States, Michigan|
|Children's Hospital of Michigan/Wayne State University|
|Detroit, Michigan, United States, 48201|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|United States, Ohio|
|Cincinnati Children's Hospital|
|Cincinnati, Ohio, United States, 45229|
|Rainbow Babies and Children's Hospital|
|Cleveland, Ohio, United States, 44106-6010|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1296|
|Principal Investigator:||Alexander Vinks, Pharm.D., Ph.D.||Children's Hospital Medical Center, Cincinnati|