Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

• ClinicalTrials.gov Identifier: NCT00555009
• Recruitment Status: Terminated
• First Posted: November 7, 2007
• Results First Posted: June 2, 2010
• Last Update Posted: June 2, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: October 24, 2007
• First Posted Date: November 7, 2007
• Results First Submitted Date: December 22, 2009
• Results First Posted Date: June 2, 2010
• Last Update Posted Date: June 2, 2010
• Study Start Date: March 2008
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 1, 2010)

Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36 [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: November 6, 2007): The primary endpoint is the change from baseline in the CogState™ composite score. [ Time Frame: At Week 36 ]

Current Secondary Outcome Measures (submitted: June 1, 2010)

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

Original Secondary Outcome Measures (submitted: November 6, 2007)

• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
• Official Title: Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Brain Injuries
• Growth Hormone Deficiency

Intervention

• 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.

Study Arms

• Experimental: Genotropin treatment arm
  Intervention: Drug: Genotropin
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 6, 2009): 10
• Original Estimated Enrollment (submitted: November 6, 2007): 120
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Italy, Netherlands, Spain, Sweden, United Kingdom

Administrative Information

• NCT Number: NCT00555009
• Other Study ID Numbers: A6281289
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: March 2009