Overview

Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

Status:
Terminated
Trial end date:
2009-01-01
Target enrollment:
0
Participant gender:
All
Summary
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Hormones
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