Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00555009
First received: October 24, 2007
Last updated: June 1, 2010
Last verified: March 2009

October 24, 2007
June 1, 2010
March 2008
January 2009   (final data collection date for primary outcome measure)
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.
The primary endpoint is the change from baseline in the CogState composite score. [ Time Frame: At Week 36 ]
Complete list of historical versions of study NCT00555009 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in CogState. [ Time Frame: At Week 12 and 24 ]
  • Change from baseline in lean body mass and fat mass. [ Time Frame: At Week 36 ]
  • Change from baseline in neurological outcome as assessed by Extended Glasgow Outcome Scale. [ Time Frame: At week 36 ]
  • Change from baseline in quality of life [ Time Frame: At week 36. ]
  • Change from baseline in cardiovascular risk.
  • Change from baseline in weight and waist circumference.
Not Provided
Not Provided
 
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Brain Injuries
  • Growth Hormone Deficiency
  • Drug: Genotropin
    Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.
  • Drug: Placebo
    Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.
  • Experimental: Genotropin treatment arm
    Not Specified
    Intervention: Drug: Genotropin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   France,   United Kingdom,   Netherlands,   Spain,   Sweden
 
NCT00555009
A6281289
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

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