Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

• Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36 [ Time Frame: Baseline, Week 36 ] [ Designated as safety issue: No ]
  CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.
  
  

• Change From Baseline in CogState™ at Week 12 and 24. [ Time Frame: Baseline, Week 12 and 24 ] [ Designated as safety issue: No ]
  CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.
  
  
• Change From Baseline in Lean Body Mass and Fat Mass at Week 36 [ Time Frame: Baseline, Week 36 ] [ Designated as safety issue: No ]
  The change from Baseline values for lean body mass and fat mass is calculated as the difference between the parameter values at Visit 36, and the parameter values at Baseline.
  
  
• Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36 [ Time Frame: Baseline, Week 36 ] [ Designated as safety issue: No ]
  The GOS is widely used for assessing outcome after head injury and non-traumatic acute brain insults and is performed by a physician. The GOS-E uses eight points to assess disability and handicap. The GOS-E focuses on how the injury has affected functioning in major areas of life rather than on the particular deficits and symptoms caused by injury. The overall score ranges from 1-8; 1=Death and 8=Upper Good Recovery
  
  
• Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36 [ Time Frame: Baseline, Week 36 ] [ Designated as safety issue: No ]
  A subject administered scale assessing general quality of life. A subject administered score, scale, direction of scale. The SF-36 consists of 36 questions covering the following eight health domains (subscales): Physical Functioning, Bodily Pain, Role Limitations Due to Physical Problems, Role Limitations Due to Emotional Problems, General Health Perceptions, Mental Health, Social Function, Vitality.
  
  
• Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36 [ Time Frame: Baseline, Week 36 ] [ Designated as safety issue: No ]
  The AGHDA is a quality of life subject-administered questionnaire that is condition-specific and comprises of 25 'Yes' or 'No' statements covering 6 dimensions - mobility, pain, energy, sleep, emotional reactions and social isolation. The AGHDA total score change from Baseline values is calculated as the difference between the total score at Visit 6 (Week 36), and the total score at Baseline.
  
  
• Change From Baseline in Cardiovascular Risk [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ] [ Designated as safety issue: No ]
  The cardiovascular risk parameters (low-density lipoprotein-cholesterol, high-density lipoprotein cholesterol, total cholesterol and fasting triglycerides) was measured at all visits (Weeks 2, 4, 12, 24, and 36).
  
  
• Change From Baseline in Weight [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ] [ Designated as safety issue: No ]
  
• Change From Baseline in Waist Circumference [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ] [ Designated as safety issue: No ]
  

The study was terminated on 15-Dec-2008 due to an inability to recruit the protocol specified patient population. The study has not been terminated due to any safety concerns.