Brain Injuries
Conditions
Brief summary
To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change from baseline in the CogState™ composite score at Week 36. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed