Phase 2
N=63
Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT00766038 ↗Enrolled (actual)
63
Serious AEs
6.4%
Results posted
Nov 2019
Primary outcome: Primary: Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index — 82.5; 82.5 Processing speed index standardized scor
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Recombinant human Growth Hormone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index |
82.5; 82.5 | — |
| SECONDARY IGF-1 Levels. |
245.5; 173.0 | — |
| SECONDARY Processing Speed Index 1 Year After Injury |
86.0; 89.5 | — |
| SECONDARY GH Response to L-arginine Stimulation at Baseline |
2.2; 1.2 | — |
| SECONDARY IGF-1 Levels |
0.1; 0.1 | — |
| SECONDARY Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema. |
0; 0; 2; 6; 0; 1 | — |
Summary
Growth Hormone (GH) deficiency, defined by insufficient GH response to a variety of stimulating compounds, is found in 20-35% of adults who suffer traumatic brain injuries (TBI) requiring inpatient rehabilitation1. However, there is no accepted gold standard for diagnosing GH deficiency in this population. Further, the major effector molecule of the somatotropic axis, Insulin-Like Growth Factor-1 (IGF-1) has recently been recognized as an important neurotrophic agent. Since most repair and regeneration after TBI occurs within the first few months after injury, absolute or relative deficiencies of GH and IGF-1 in the subacute period after TBI are potentially important factors why some patients fail to make a good functional recovery. The proposed study is a randomized, double-blind, placebo-controlled trial of rhGH, starting at 1 month post TBI, continuing for 6 months.
This study has one primary hypothesis, that treatment with recombinant human Growth Hormone (rhGH) in the subacute period after TBI results in improved functional outcome 6 months after injury. As secondary hypotheses, we will investigate what is the optimal method to diagnose GH deficiency in TBI survivors and study the relationship between GH deficiency and insufficiency and functional recovery.
Eligibility Criteria
Inclusion Criteria
- Non-penetrating TBI
- Age 18 - 50 years.
- Admission to a North Texas Traumatic Brain Injury Model System-affiliated rehabilitation unit within 8 weeks of injury. Enrollment in TBI-MS database not required.
- Randomization within 2 - 10 weeks of injury.
- Rancho Los Amigos Rating IV or better at the time of randomization. Should not be at Rancho IV level for more than 4 weeks before randomization.
- GH deficiency diagnosed by either of the following two criteria:
- . Peak GH response to L-arginine stimulation test 30).
- Active infection.
- Active malignant disease.
- Acute critical illness, heart failure, or acute respiratory failure
- Previous hospitalization for TBI > 1 day
- Membership in a vulnerable population (prisoner)
- Pregnancy. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy.
- Lactating females
Data sourced from ClinicalTrials.gov (NCT00766038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.