Traumatic Brain InjuryPhase 1NCT02114775
Growth Hormone or Sildenafil as Therapies for Fatigue in Mild- Traumatic-brain-injury (MTBI)
A Phase 1 study testing Growth Hormone and Sildenafil in people with Traumatic Brain Injury, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The overall goal is to determine whether perceptual or performance fatigue can be reduced in MTBI patients with and without growth hormone (GH) deficiency by treating them in a crossover fashion based upon GH status. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Growth Hormone and Sildenafil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2014to 10 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female with a diagnosis of mild TBI and 6 month post-injury. Age 18 to 60 years. Complaint of fatigue, with score of 3 or greater on questions 1, 2, or 3 of the Brief Fatigue Inventory.
Who cannot join
- Significant heart, liver, kidney, blood or respiratory disease.
- Active coronary disease.
- Pregnancy.
- Alcohol or drug abuse.
- Unable to walk unassisted.
- Diabetes mellitus and anterior pituitary abnormalities diagnosed upon screening.
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- Premorbid history of psychiatric disorder.
- Premorbid history of head trauma.
- Use of nitrates.
- Use of alpha blockers.
- Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >90. This range is smaller than the acceptable range stated in the prescribing information for sildenafil (>90/50 and <170/110).
- Peripheral vascular disease.
- Use of a phosphodiesterase 5 inhibitor.
- Coumadin because of the risk of bleeding with daily injections of Recombinant Human Growth Hormone (rhGH) in the growth hormone (GH) arm of the study.
- Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
- Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Growth Hormone or Sildenafil as Therapies for Fatigue in MTBI
The overall goal is to determine whether perceptual or performance fatigue can be reduced in MTBI patients with and without growth hormone (GH) deficiency by treating them in a crossover fashion based upon GH status.
A battery of functional, fatigue, cognitive, imaging and blood flow tests will be performed to assess the efficacy of the two drug interventions, Growth hormone and Sildenafil.
Read the detailed description
Three primary outcome measures are proposed:
- Perceptual fatigue as measured weekly using the Brief Fatigue Inventory (BFI) (59).
- Performance fatigue as measured at baseline and month 3, 6 and 12 using hand and leg dynamometry.
- Neuropsychological function as measured at baseline and month 12.
Secondary outcomes will include:
- Modified 6 minute walk performance as measured at baseline, and month 3, 6 and 12.
- Mood and quality of life using the Profile of Mood States, Quality of Life Assessment of GH Deficiency in Adults questionnaire, and a grief assessment (60) (POMS), measured at baseline, and month 3, 6, and 12.
- Sleep quality using the Pittsburgh Sleep Quality Index (PSQI), baseline, and month 3, 6, and 12.
- Multidimensional fatigue using Multidimensional Fatigue Symptom Inventory (MFSI) at baseline, and month 3, 6 and 12.
- Skeletal muscle mass, as derived from lean body mass determinations, using dual energy X-ray absorptiometry (iDEXA) at baseline, and month 3, 6, and 12.
- Physical Activity, measured daily using accelerometry.
- Cerebral blood oxygen saturation measured at baseline and month 12.
- Leg blood flow measured at baseline, and month 3, 6 and 12.
- Blood Hormones at baseline and month 3, 6 and 12.
- Characterization of brain tissue using structural, "resting state" and diffusion functional MR at baseline and month 3, 6, and 12.
- Indirect calorimetry measured at baseline and month 3, 6 and 12.
- Conditions
- Traumatic Brain Injury
- Being tested
- Growth Hormone, Sildenafil, Placebo
- Keywords
- mild traumatic brain injury, growth hormone, fatigue, sildenafil, neurology
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth HormoneDrug
Also called Genotropin
0.4 mg/day injected subcutaneously for one month then increased to 0.6 mg/day for two months during crossover phase. After crossover phase, 0.6 mg/day for six months
SildenafilDrug
Also called Viagra
50 mg by mouth daily
PlaceboDrug
Placebo either injected (GH group) or orally (sildenafil group) daily for three months during crossover phase of the study
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Growth Hormone | Active comparator | Double blind placebo/Genotropin cross over design for 6 months with cross over at 3 months. Then open label Genotropin from month 6 - 12. Receives: Drug: Growth Hormone; Drug: Placebo |
| Sildenafil | Active comparator | Double blinded placebo/Sildenafil crossover design for 6 months with crossover at month 3. Then open label Sildenafil from months 6-12. Receives: Drug: Sildenafil; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance fatigue as measured by using hand grip dynamometry at baseline
Hand grip exercises will be used to measure performance fatigue at baseline
Measured: baseline
Performance fatigue as measured by using hand grip dynamometry at 3 months
Hand grip exercises will be used to measure performance fatigue after 3 months of study intervention
Measured: 3 months
Performance fatigue as measured by using hand grip dynamometry at 6 months
Hand grip exercises will be used to measure performance fatigue after 6 months of study intervention
Measured: 6 months
Performance fatigue as measured by using hand grip dynamometry at 12 months
Hand grip exercises will be used to measure performance fatigue after 12 months of study intervention
Measured: 12 months
Performance fatigue as measured by using leg dynamometry at baseline
Leg exercises will be used to measure performance fatigue at baseline
Measured: baseline
Performance fatigue as measured by using leg dynamometry at 3 months
Leg exercises will be used to measure performance fatigue after 3 months of study intervention.
Measured: 3 months
Performance fatigue as measured by using leg dynamometry at 6 months
Leg exercises will be used to measure performance fatigue after 6 months of study intervention.
Measured: 6 months
Performance fatigue as measured by using leg dynamometry at 12 months
Leg exercises will be used to measure performance fatigue after 12 months of study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study start12 Dec 2014
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall J Urban, MD, Principal investigator, University of TexasMelinda Sheffield-Moore, PhD, Principal investigator, University of TexasBrent Masel, MD, Principal investigator, Transitional Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114775
- Sponsor's protocol ID
- 13-0324
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2014
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone or Sildenafil as Therapies for Fatigue in MTBI
- ClinicalTrials.gov ID
- NCT02114775
- Acronym / sponsor ID
- 13-0324
- Conditions
- Traumatic Brain Injury
- Keywords
- mild traumatic brain injury, growth hormone, fatigue, sildenafil, neurology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 12 Dec 2014 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal is to determine whether perceptual or performance fatigue can be reduced in MTBI patients with and without growth hormone (GH) deficiency by treating them in a crossover fashion based upon GH status.
A battery of functional, fatigue, cognitive, imaging and blood flow tests will be performed to assess the efficacy of the two drug interventions, Growth hormone and Sildenafil.
Detailed description
Three primary outcome measures are proposed:
- Perceptual fatigue as measured weekly using the Brief Fatigue Inventory (BFI) (59).
- Performance fatigue as measured at baseline and month 3, 6 and 12 using hand and leg dynamometry.
- Neuropsychological function as measured at baseline and month 12.
Secondary outcomes will include:
- Modified 6 minute walk performance as measured at baseline, and month 3, 6 and 12.
- Mood and quality of life using the Profile of Mood States, Quality of Life Assessment of GH Deficiency in Adults questionnaire, and a grief assessment (60) (POMS), measured at baseline, and month 3, 6, and 12.
- Sleep quality using the Pittsburgh Sleep Quality Index (PSQI), baseline, and month 3, 6, and 12.
- Multidimensional fatigue using Multidimensional Fatigue Symptom Inventory (MFSI) at baseline, and month 3, 6 and 12.
- Skeletal muscle mass, as derived from lean body mass determinations, using dual energy X-ray absorptiometry (iDEXA) at baseline, and month 3, 6, and 12.
- Physical Activity, measured daily using accelerometry.
- Cerebral blood oxygen saturation measured at baseline and month 12.
- Leg blood flow measured at baseline, and month 3, 6 and 12.
- Blood Hormones at baseline and month 3, 6 and 12.
- Characterization of brain tissue using structural, "resting state" and diffusion functional MR at baseline and month 3, 6, and 12.
- Indirect calorimetry measured at baseline and month 3, 6 and 12.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Growth Hormone | Active comparator | Drug: Growth Hormone, Drug: PlaceboDouble blind placebo/Genotropin cross over design for 6 months with cross over at 3 months. Then open label Genotropin from month 6 - 12. |
| Sildenafil | Active comparator | Drug: Sildenafil, Drug: PlaceboDouble blinded placebo/Sildenafil crossover design for 6 months with crossover at month 3. Then open label Sildenafil from months 6-12. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or female with a diagnosis of mild TBI and 6 month post-injury. Age 18 to 60 years. Complaint of fatigue, with score of 3 or greater on questions 1, 2, or 3 of the Brief Fatigue Inventory.
Key exclusion criteria (16 listed)
- Significant heart, liver, kidney, blood or respiratory disease.
- Active coronary disease.
- Pregnancy.
- Alcohol or drug abuse.
- Unable to walk unassisted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth HormoneAlso: Genotropin0.4 mg/day injected subcutaneously for one month then increased to 0.6 mg/day for two months during crossover phase. After crossover phase, 0.6 mg/day for six months | Drug | Recombinant Growth Hormone |
| SildenafilAlso: Viagra50 mg by mouth daily | Drug | Sildenafil |
| PlaceboPlacebo either injected (GH group) or orally (sildenafil group) daily for three months during crossover phase of the study | Drug | Recombinant Growth Hormone, Sildenafil |
Primary outcome
Performance fatigue as measured by using hand grip dynamometry at baseline
Time frame: baseline
Hand grip exercises will be used to measure performance fatigue at baseline
Performance fatigue as measured by using hand grip dynamometry at 3 months
Time frame: 3 months
Hand grip exercises will be used to measure performance fatigue after 3 months of study intervention
Performance fatigue as measured by using hand grip dynamometry at 6 months
Time frame: 6 months
Hand grip exercises will be used to measure performance fatigue after 6 months of study intervention
Performance fatigue as measured by using hand grip dynamometry at 12 months
Time frame: 12 months
Hand grip exercises will be used to measure performance fatigue after 12 months of study intervention
Performance fatigue as measured by using leg dynamometry at baseline
Time frame: baseline
Leg exercises will be used to measure performance fatigue at baseline
Performance fatigue as measured by using leg dynamometry at 3 months
Time frame: 3 months
Leg exercises will be used to measure performance fatigue after 3 months of study intervention.
Performance fatigue as measured by using leg dynamometry at 6 months
Time frame: 6 months
Leg exercises will be used to measure performance fatigue after 6 months of study intervention.
Performance fatigue as measured by using leg dynamometry at 12 months
Time frame: 12 months
Leg exercises will be used to measure performance fatigue after 12 months of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall J Urban, MD principal investigator
University of Texas
Melinda Sheffield-Moore, PhD principal investigator
University of Texas
Brent Masel, MD principal investigator
Transitional Learning Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Growth Hormone and Sildenafil in people with Traumatic Brain Injury, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance fatigue as measured by using hand grip dynamometry at baseline (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.