Clonidine for Neurocognitive Sequelae

NCT00166686 | Withdrawn Phase 1

• 1 other identifier: PPRU 10706
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Treatment-Related Cancer

Keywords

Cancer; Clonidine; Neurocognitive sequelae

Interventions

Clonidine DRUG

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with a prior diagnosis of a pediatric malignancy (brain tumors, solid tumors, leukemia/lymphoma) who are in remission, and are \> 3 years from initial diagnosis. Patients must have completed therapy a minimum of 6 months prior to study entry.
• Patients must have English as their primary language
• Patients must be \>3 and less than or equal to 16 at the time of study enrollment
• Patients must fulfill the operational criteria for neurocognitive deficit and have an IQ \> 50.
• Patients must be currently enrolled in a school or a learning environment where an adult familiar with the child's academic performance can provide ratings of that performance over the time of the trial.
• Patients must have wbc, hemoglobin and platelet parameters which fall within the norms for the patient's age.
• Patients must have adequate hepatic function (bilirubin less than or equal to 1.5 mg/dl and SGPT \< 5x normal) and renal function (normal Cr for age/GFR greater than or equal to 70 ml/min/1.73m2)
• Patients must be able to swallow gel caps.
• Signed informed consent must be obtained according to institutional guidelines. When appropriate the patient will be included in all discussion in order to obtain verbal assent.
• Protocol and informed consent must be approved by the local IRB prior to any patient registration and reapproved every 12 months.

You may not qualify if:

• Patients who have evidence of a significant neurological abnormality prior to their cancer diagnosis that would affect neuro-behavioral development (such as genetic: Fragile X, Downs syndrome, or acquired disorders: closed head injury)
• Patients with a prior (pre-cancer) diagnosis of attention deficit hyperactivity disorder or major depression
• Patients who have a medical condition which would preclude the use of clonidine (medicated for hypertension, cardiac conduction disturbances, cerebrovascular disease, or chronic renal failure)
• Patients must not have received psychotropic medication (SSRIs, methylphenidate), anxiolytics, or hypnotics within 2 weeks of study entry.
• Patients who are receiving concurrent scheduled barbiturates or sedating drugs.
• Currently (within 6 months) known to abuse drugs or to be dependent on any drug including alcohol or with a positive urine drug screen.
• Women of childbearing age must not be pregnant or lactating. This group is excluded because of teratogenic potential of this agent demonstrated in rat and rabbit models.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms, Second Primary; Neoplasms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

US (1)