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