Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

Phase 4

Terminated

Conditions: Brain Injuries
Growth Hormone Deficiency

Interventions: Drug: Genotropin
Drug: Placebo

Registration Number: NCT00555009

Lead Sponsor: Pfizer

Brief Summary: To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

Inclusion Criteria

Have had a previous traumatic brain injury (more than 1 year and less than 20 years) prior to the screening visit.
Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.
Have proven GHD deficiency

Exclusion Criteria

Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.
Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.
History of dementia unrelated to TBI
History of benign intracranial hypertension

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genotropin treatment arm	Genotropin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36	Baseline, Week 36	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36	Baseline, Week 36	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 Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36	Baseline, Week 36	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 Weight	Baseline, Weeks 2, 4, 12, 24, and 36
Change From Baseline in CogState™ at Week 12 and 24.	Baseline, Week 12 and 24	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	Baseline, Week 36	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 Quality of Life Using Short Form (SF)-36 Health Survey at Week 36	Baseline, Week 36	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 Cardiovascular Risk	Baseline, Weeks 2, 4, 12, 24, and 36	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 Waist Circumference	Baseline, Weeks 2, 4, 12, 24, and 36