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Hormone Therapy

Growth Hormone Therapy for Human Growth Hormone Deficiency

Phase 2
Recruiting
Led By Randall R Benson, MD
Research Sponsored by Center for Neurological Studies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Less than 76 years of age
Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD
Must not have
Active malignant disease
Contraindication to GH therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 1-year post-treatment
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial is testing whether growth hormone can improve cognitive function in retired professional football players with growth hormone deficiency.

Who is the study for?
This trial is for retired NFL players under 76 years old with growth hormone deficiency (GHD) diagnosed by a neurologist and endocrinologist. They must understand the study, be willing to participate, and have been retired for at least one year. Those with diabetes, pre-existing brain diseases other than concussion or TBI, conditions affecting assessments, contraindications to GH therapy, active cancer, acute illnesses or untreated hormonal deficiencies cannot join.
What is being tested?
The trial tests if growth hormone (GH) improves cognitive functions in these athletes compared to a placebo. Participants are randomly assigned to receive either GH or placebo without knowing which they're getting. After this phase ends, there's an open-label extension where everyone knows they're receiving GH.
What are the potential side effects?
Possible side effects of growth hormone therapy include joint pain, swelling due to fluid in the body's tissues (edema), carpal tunnel syndrome-like symptoms such as numbness and tingling of the hands and fingers, muscle pain and increased cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am younger than 76 years old.
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I have been diagnosed with growth hormone deficiency by both a neurologist and an endocrinologist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have cancer.
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I cannot take growth hormone therapy due to health risks.
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I do not have any acute critical illnesses, heart failure, or acute respiratory issues.
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I have a brain condition other than a concussion or TBI.
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I have been diagnosed with Type I or Type II diabetes.
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My hormone levels, including cortisol, testosterone, and thyroid, are normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 1-year post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 1-year post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cognitive functions- ANAM ( Automated Psychological Assessment Metrics)
Cognitive functions- Executive Function.
Cognitive functions- Processing Speed
+2 more
Secondary study objectives
Adverse events
Change in Physical function- Isokinetic knee extension peak torque
Change in Physical function- Maximum grip strength
+6 more
Other study objectives
MR imaging analysis of hypothalamus and pituitary

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Growth HormoneExperimental Treatment1 Intervention
Norditropin® (somatropin \[rDNA origin\] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).
Group II: SalinePlacebo Group1 Intervention
Saline-placebo via auto-injector pens (Haselmeier Inc).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somatotropin
FDA approved

Find a Location

Who is running the clinical trial?

Center for Neurological StudiesLead Sponsor
Novo Nordisk A/SIndustry Sponsor
1,559 Previous Clinical Trials
3,646,365 Total Patients Enrolled
7 Trials studying Human Growth Hormone Deficiency
729 Patients Enrolled for Human Growth Hormone Deficiency
Randall R Benson, MDPrincipal InvestigatorVice President and Medical Director

Media Library

Growth Hormone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04121780 — Phase 2
Human Growth Hormone Deficiency Research Study Groups: Growth Hormone, Saline
Human Growth Hormone Deficiency Clinical Trial 2023: Growth Hormone Highlights & Side Effects. Trial Name: NCT04121780 — Phase 2
Growth Hormone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04121780 — Phase 2
~1 spots leftby Mar 2025
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