Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

Phase 4TerminatedNCT00555009

Pfizer10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Brain Injuries Growth Hormone Deficiency

Interventions

GenotropinDRUG

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.

PlaceboDRUG

Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (9)

Pfizer Investigational Site

Créteil, France

Pfizer Investigational Site

Paris, France

Pfizer Investigational Site

Ferrara, Italy

Pfizer Investigational Site

Roma, Italy

Outcomes

Primary Outcomes

Change From Baseline in the Cognitive Function (CogState™) Composite Score at 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.

Time frame: Baseline, Week 36

Secondary Outcomes

Change From Baseline in CogState™ at Week 12 and 24.

Time frame: Baseline, Week 12 and 24

Change From Baseline in Lean Body Mass and Fat Mass at 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.

Time frame: Baseline, Week 36

Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at 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

Data from ClinicalTrials.gov

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