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Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury. (Growth-TBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00766038
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
Baylor Health Care System
Information provided by (Responsible Party):
Ramon Diaz-Arrastia, University of Pennsylvania

Brief 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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Recombinant human Growth Hormone Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Controlled Trial of Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
Study Start Date : September 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Recombinant human Growth Hormone
400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements
Other Names:
  • Somatotropin
  • Genotropin(R)
  • HGH

Placebo Comparator: 2
Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding.
Drug: Placebo
SC injection daily




Primary Outcome Measures :
  1. Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index [ Time Frame: 6 months ]

    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 Outcome Measures :
  1. IGF-1 Levels. [ Time Frame: 4 years ]
    Serum levels of Insulin-Like Growth Factor-1.

  2. Processing Speed Index 1 Year After Injury [ Time Frame: 1 year ]

    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


  3. GH Response to L-arginine Stimulation at Baseline [ Time Frame: 1 day ]
    Measurement of serum GH levels over 90 minutes after administration of L-arginine

  4. IGF-1 Levels [ Time Frame: Baseline ]
    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.

  5. Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema. [ Time Frame: 4 years ]
    Rates of diabetes mellitus, arthralgias, or peripheral edema between rhGH treatment and placebo.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766038


Locations
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United States, California
Center for NeuroSkills
Bakersfield, California, United States
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75226
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9036
Sponsors and Collaborators
University of Pennsylvania
Baylor Health Care System
Investigators
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Principal Investigator: Ramon R. Diaz-Arrastia, MD, PhD University of Texas Southwestern Medical Center
Study Director: Randi Dubiel, MD Baylor Health Care System
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Responsible Party: Ramon Diaz-Arrastia, Professor of Neurology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00766038    
Other Study ID Numbers: NTTBIMS-GH RCT
NIDRR H133A07002708
Pfizer GA62816O
First Posted: October 3, 2008    Key Record Dates
Results First Posted: November 18, 2019
Last Update Posted: November 18, 2019
Last Verified: November 2019
Keywords provided by Ramon Diaz-Arrastia, University of Pennsylvania:
Mood disorders
Cognitive disorders
Fatigue
Metabolic disorders
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs