Androgen Effect on Klinefelter Syndrome Motor Outcome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Thomas Jefferson University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00348946
First received: July 3, 2006
Last updated: June 4, 2012
Last verified: June 2012

July 3, 2006
June 4, 2012
July 2006
April 2014   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00348946 on ClinicalTrials.gov Archive Site
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Androgen Effect on Klinefelter Syndrome Motor Outcome
Androgen Effect on Motor/Cognitive Outcome in Klinefelter Syndrome

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Klinefelter Syndrome
  • Drug: androgen oxandrolone
    Oxandrolone or placebo capsule, .06 >mg/kg/day, orally, for 2 years
  • Other: placebo
    an inactive substance
  • Active Comparator: 1
    Intervention: Drug: androgen oxandrolone
  • Placebo Comparator: 2
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Karyotype diagnosis of Klinefelter syndrome
  • Chronological age of 4-12 years
  • No treatment with androgen in the past year

Exclusion Criteria:

  • Major liver, kidney or other systemic disease
  • Variant karyotypes including 47,XYY males
  • Evidence of spontaneous onset of puberty, defined as testicular size > 4ml
Male
4 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00348946
R01NS050597-01A2
Yes
Thomas Jefferson University
Thomas Jefferson University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Judith L. Ross, M.D. Thomas Jefferson University
Thomas Jefferson University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP