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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 3, 2006 | ||||
| Last Updated Date | July 14, 2009 | ||||
| Start Date ICMJE | July 2006 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evaluation of several aspects of motor function including muscle strength, motor response speed, simple repetitive movement, and complex nonrepetitive motor action, previously shown to be impaired in boys with Klinefelter syndrome. [ Time Frame: 2 years per subject ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Evaluation of several aspects of motor function including muscle strength, motor response speed, simple repetitive movement, and complex nonrepetitive motor action, previously shown to be impaired in boys with Klinefelter syndrome. | ||||
| Change History | Complete list of historical versions of study NCT00348946 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Androgen Effect on Klinefelter Syndrome Motor Outcome | ||||
| Official Title ICMJE | Androgen Effect on Motor/Cognitive Outcome in Klinefelter Syndrome | ||||
| Brief Summary | The purpose of this study is to evaluate the effects of low-dose androgen on the motor and cognitive development of boys with Klinefelter syndrome. |
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| Detailed Description | Klinefelter syndrome (KS), a genetic disorder that affects males only, is characterized by having an extra X chromosome. The phenotype — or physical and learning features — includes testicular failure, tall stature, and specific cognitive and behavioral attributes such as diminished motor function, language-based learning difficulties, poor self-image, and shyness. The KS phenotype may be the result of androgen deficiency in utero, infancy, and childhood. For individuals with KS, androgen replacement is standard treatment in adolescence and adulthood but has not been used earlier in childhood or included in the standard medical care of KS children ages 4 to 12. The purpose of this study is to examine the effects of androgen on learning and development in boys with KS. Researchers also want to determine if low-dose androgen replacement at an early age will improve some of the learning difficulties associated with the disorder. The overall goal of this study is to address questions regarding the relationship of early androgen deficiency to learning and motor function. Participants in the study will be randomized to one of two treatment groups, receiving either oxandrolone (low-dose androgen) or placebo, for two years. All participants will be evaluated for safety at the beginning of the study and at 3, 6, 12, 18, and 24 months. Also at the beginning of the study and every 3 to 6 months thereafter (for a total of 6 visits), the researchers will perform a careful history and physical examination and a bone age X-ray, and obtain a blood sample. Participation in the trial will last two years and includes 6 clinic visits. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study | ||||
| Condition ICMJE | Klinefelter Syndrome | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | April 2014 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 4 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00348946 | ||||
| Responsible Party | Roseann Talarico, Associate Director, Office of Human Research, Thomas Jefferson University | ||||
| Study ID Numbers ICMJE | R01NS050597-01A2 | ||||
| Study Sponsor ICMJE | Thomas Jefferson University | ||||
| Collaborators ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
| Investigators ICMJE |
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| Information Provided By | Thomas Jefferson University | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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