Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.

Pfizer

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Brain Injuries

Interventions

Genotropin (PN-180,307) SomatropinDRUG

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 5 years) prior to the screening visit. * Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5. 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.

Outcomes

Primary Outcomes

The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.

Secondary Outcomes

Change CogState™ at Week 12, 24, 60 and 72. Change in lean body mass and fat mass at Week 36 and 72. Change in the Extended Glasgow Outcome Scale at week 36 and 72. Change in quality of life at week 24, 36, 60 and 72. Summary of change in cardiovascular

Data from ClinicalTrials.gov

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