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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00166686 |
Purpose
The goals of the study are to determine the efficacy of clonidine in the treatment of children with neurocognitive sequelae following the therapy of long term malignancies. In addition, the study hopes to determine the long-term effect of clonidine on children's academic and psychosocial function.
| Condition | Intervention | Phase |
|---|---|---|
|
Treatment-Related Cancer |
Drug: Clonidine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Clonidine for the Treatment of Neurocognitive Sequelae Following Cancer Treatment in Children |
| Estimated Enrollment: | 24 |
The long term prognosis for many children diagnosed with brain tumors and other malignancies has improved dramatically over the last decades and is expected to continue to rise as a result of improved treatment. The increased survival in pediatric oncology, however, has been associated with an increased recognition of neurobehavioral sequelae of cancer and its treatment. Current understanding of the incidence, pathogenesis, and natural history of these neurobehavioral abnormalities is limited and considerable individual variation in the presence and severity of these complications has been noted. Central nervous system (CNS) abnormalities associated with childhood cancer and its treatment have been demonstrated on at least three levels which may be interrelated: neurobehavioral abnormalities, brain imaging abnormalities, and neurotransmitter abnormalities.
Patients will be randomized to either clonidine or placebo. Study medication will be administered in a double blind fashion beginning with a four-week dose titration period followed by a four-week maintenance period. Total duration of dosing is 18 weeks. Patients who derive a benefit from clonidine administration may continue for an additional 30 weeks of therapy. PK samples will be collected at weeks 9 and 18.
Eligibility| Ages Eligible for Study: | 5 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00166686 History of Changes |
| Other Study ID Numbers: | PPRU 10706 |
| Study First Received: | September 9, 2005 |
| Last Updated: | March 22, 2011 |
| Health Authority: | United States: Federal Government |
|
Cancer Clonidine Neurocognitive sequelae |
|
Neoplasms, Second Primary Neoplasms Clonidine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents |