Ongoing Studies for Clinical Trials as of June 1, 2006
| Performer/ Contractor | Drug/Indication | Type of Study |
|---|
| Case Western Reserve University | Lithium for the treatment of pediatric mania | Phase I - Pharmacokinetics study;
Phase II - 8-week, randomized, placebo-controlled, double-blind study |
| Children's National Medical Center | Lorazepam for the treatment for status epilepticus | Phase I - Pharmacokinetics study |
| Case Western Reserve University | Lorazepam for the sedation of children on respirators in an intensive care unit | Randomized double-blind active comparator |
| Duke University | Nitroprusside for the control of blood pressure | Randomized double-blind parallel group |
| Stanford University | Nitroprusside for the control of blood pressure | Randomized double-blind parallel group |
Inter-Agency Activities for Preclinical and Clinical Studies
| Drugs/Purpose | Organization | Trial design | Initiated |
|---|
| Ketamine - To evaluate the scientific and safety concerns about the use as an anesthetic in children | FDA | Preclinical toxicology studies in primates | September 2004 |
| Vincristine and Dactinomycin - Safety and efficacy of treatment for malignancies in children | National Cancer Institute's (NCI) Children's Oncology Group | Data collection and pharmacokinetic studies | September 2004 |
| Hydroxyurea - To determine the safety and efficacy of hydroxyurea in children with sickle cell disease (SCD) | National Heart, Lung, and Blood Institute Pediatric Hydroxyurea Phase III Clinical Trial (Baby Hug) | Phase III clinical trial | July 2005 |
| Methotrexate - To evaluate methotrexate-related neurotoxicity | NCI Children's Oncology Group | Randomized 2x2 factorial design | August 2005 |
| Methylphenidate - To evaluate the genetic toxicity of methylphenidate in mice and monkeys. The information from these experiments will enhance our ability to conduct a safety assessment of methylphenidate in humans | FDA | Pre-clinical studies in mice and monkeys | August 2005 |
| Methylphenidate - to evaluate the effects of methylphenidate and Adderall on specific chromosomal damage endpoints in lymphocytes of children who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) | National Institute of Environmental Health Sciences | Longitudinal observational study of pediatric ADHD patients | August 2005 |
| Daunomycin - To determine the pharmacokinetics of daunomycin in children | NCI Children's Oncology Group | Pharmacokinetic studies | September 2005 |