Primary outcomeMedian· 6 months
Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index
| Group | Value (Processing speed index standardized scor) |
|---|---|
| rhGH Treatment | 82.5 |
| Placebo Treament | 82.5 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataRecombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
Short name Growth-TBI
NCTNCT00766038 (opens ClinicalTrials.gov in a new tab)Other idNTTBIMS-GH RCTOther idNIDRR H133A07002708Other idPfizer GA62816O
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 63 participants (actual)
- Sponsor
- University of Pennsylvania · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Sept 2008
- Primary completion
- Jun 2013
- Completion
- Dec 2013
- First posted
- 3 Oct 2008 (estimated)
- Last update posted
- 18 Nov 2019
- Conditions
- Traumatic Brain Injury
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2008200920102011201220132014
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Recombinant human Growth HormoneDrug
- PlaceboDrug
Arms2
Experimental
1
The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment.
Placebo comparator
2
Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding.
Primary outcomes1
Outcomes the sponsor listed as primary.
Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index
Time frame · 6 months
Registry description
Processing Speed Index ages standardized score. In this scale, higher scores represent better functioning, lower scores represent poorer function. 100 = mean of a normative population. 110 = 1 standard deviation above normal; 90 = 1 standard deviation below normal 120 = 2 standard deviations above normal; 80 = 2 standard deviations below normal
Secondary outcomes(5)
IGF-1 Levels.
Time frame · 4 years
Registry description
Serum levels of Insulin-Like Growth Factor-1.
Processing Speed Index 1 Year After Injury
Time frame · 1 year
Registry description
Processing Speed Index ages standardized score. In this scale, higher scores represent better functioning, lower scores represent poorer function. 100 = mean of a normative population. 110 = 1 standard deviation above normal; 90 = 1 standard deviation below normal 120 = 2 standard deviations above normal; 80 = 2 standard deviations below normal
GH Response to L-arginine Stimulation at Baseline
Time frame · 1 day
Registry description
Measurement of serum GH levels over 90 minutes after administration of L-arginine
IGF-1 Levels
Time frame · Baseline
Registry description
Serum IGF-1 levels at baseline for both treatment groups was correlated with the Processing Speed Index recorded at baseline, using Pearson's correlation coefficient. Perason's correlation coefficient is a measure of the linear correlation between two variables X and Y. It has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema.
Time frame · 4 years
Registry description
Rates of diabetes mellitus, arthralgias, or peripheral edema between rhGH treatment and placebo.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeMedian· 4 years
IGF-1 Levels.
| Group | Value (ng/mL) |
|---|---|
| Active Treatment With Recombinant Human Growth Hormone | 245.5 |
| Placebo Treatment | 173.0 |
Secondary outcomeMedian· 1 year
Processing Speed Index 1 Year After Injury
| Group | Value (Processing speed index standardized scor) |
|---|---|
| Active Treatment With Recombinant Human Growth Hormone | 86.0 |
| Placebo Treatment | 89.5 |
Secondary outcomeMedian· 1 day
GH Response to L-arginine Stimulation at Baseline
| Group | Value (ng/mL) |
|---|---|
| Active Treatment With Recombinant Human Growth Hormone | 2.2 |
| Placebo Treatment | 1.2 |
Secondary outcomeNumber· Baseline
IGF-1 Levels
| Group | Value (Pearson's correlation coefficient) |
|---|---|
| Active Treatment With Recombinant Human Growth Hormone | 0.1 |
| Placebo Treatment | 0.1 |
Secondary outcomeCount of participants· 4 years
Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema.
| Group | Value (Participants) |
|---|---|
| Active Treatment With Recombinant Human Growth Hormone | 0 |
| Placebo Treatment | 0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Recombinant Human Growth HormoneThe GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements | 0 / 31 | 2 / 31 | 12 / 31 |
| Placebo TreatmentDoses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily | 0 / 32 | 2 / 32 | 15 / 32 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 50 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Non-penetrating TBI
2. Age 18 - 50 years.
3. 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.
4. Randomization within 2 - 10 weeks of injury.
5. 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.
6. GH deficiency diagnosed by either of the following two criteria:
1. . Peak GH response to L-arginine stimulation test \< 1.4 microg/L; or
2. . Plasma IGF-1 level 1 SD below the expected median for age and body weight.
7. Availability of caregiver to oversee administration of medications.
8. Reasonable expectation for completion of outcome measures
9. Residence inside the United States
Exclusion Criteria:
1. History of pre-existing neurologic disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis)
2. History of premorbid disabling condition that interfere with outcome assessments
3. Contraindication to rhGH therapy. (hypersensitivity to rhGH or any of the components of the supplied product, including metacresol, glycerin, or benzyl alcohol)
4. Penetrating traumatic brain injury
5. Diabetes mellitus.
6. Obesity (BMI \> 30).
7. Active infection.
8. Active malignant disease.
9. Acute critical illness, heart failure, or acute respiratory failure
10. Previous hospitalization for TBI \> 1 day
11. Membership in a vulnerable population (prisoner)
12. Pregnancy. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy.
13. Lactating females
PepBank is a research reference. Talk to a doctor before you use any peptide.