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Locomotor Training + Testosterone for Spinal Cord Injury
Phase 2
Recruiting
Led By Dana M Otzel, Phd
Research Sponsored by North Florida Foundation for Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months, 6 months
Awards & highlights
Summary
This trial will study the feasibility of using testosterone replacement therapy along with locomotor training to improve walking function in men with spinal cord injuries and low testosterone levels.
Who is the study for?
Men over 18 with low testosterone and spinal cord injury (SCI) causing walking difficulties are eligible. They must be medically stable, not seeking fertility, and willing to follow the treatment plan. Exclusions include major recent surgeries, other serious health conditions or cancers, certain cardiovascular issues, severe kidney disease, untreated sleep apnea, specific bone density scores below a threshold.Check my eligibility
What is being tested?
The study tests whether combining testosterone replacement therapy (TRT) with locomotor training (treadmill and overground walking assistance) improves muscle size, bone density, and walking in men with SCI and low testosterone levels.See study design
What are the potential side effects?
Potential side effects of TRT may include acne or oily skin, increased red blood cell count which can lead to complications like blood clots if too high; mood swings or aggression; possible increase in risk for heart-related events; enlargement of breasts; reduced sperm production.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in 6 min walk test (6MWT)
change in distal femur bone mineral density
change in thigh muscle cross-sectional area
Secondary outcome measures
change in 10m walk test (10mWT)
change in bone formation marker
change in bone resorption marker
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: testosterone enanthateExperimental Treatment1 Intervention
Testosterone enanthate via i.m. injection (100 mg/week)
Group II: locomotor training, testosterone enanthateExperimental Treatment2 Interventions
Treadmill and overground walking training and testosterone enanthate via i.m. injection (100 mg/week)
Group III: non-interventional controlActive Control1 Intervention
Non-interventional control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Locomotor Training
2013
Completed Phase 1
~110
Testosterone enanthate
FDA approved
Find a Location
Who is running the clinical trial?
North Florida Foundation for Research and EducationLead Sponsor
13 Previous Clinical Trials
838 Total Patients Enrolled
North Florida/South Georgia Veterans Health SystemOTHER
7 Previous Clinical Trials
1,964 Total Patients Enrolled
Brooks RehabilitationOTHER
13 Previous Clinical Trials
1,722 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Men who are older than 18 years.Your testosterone levels are too low.For men, your PSA level is higher than 3.0 ng/mL, unless you are taking certain medications and your PSA level is 1.5 ng/mL or less.You have a heart rhythm problem that is not well controlled.Your liver enzymes (AST or ALT) are more than 1.5 times the normal level.You are allergic to any ingredient in the TRT formulation, like sesame oil or cottonseed oil.You have a serious problem with one of your heart valves.You are not expected to live for more than 12 months.You have a spinal condition that could make it difficult to participate in the study.You have conditions like multiple sclerosis, amyotrophic lateral sclerosis, or other nervous system problems.You have prostate, breast, or any other type of cancer now or in the past.You have been diagnosed or treated for any other type of cancer within the past 24 months, except for certain types of skin cancer that have been successfully treated.You have a lump or hard area in your prostate found during a rectal exam that could be a sign of prostate cancer.You have enlarged male breasts.Your hematocrit level is higher than 49%.You had a serious heart or blood vessel problem in the past year, like a heart attack, needing a procedure to open blocked arteries, or being hospitalized for certain heart or blood vessel conditions.You have severe or uncontrolled chest pain despite taking medication.You have severe congestive heart failure that is not well controlled.Your high blood pressure is not well controlled even with medication.Your initial ECG shows certain unusual patterns that would make it difficult to check for hidden heart problems in the future.You have had blood clots in your veins for no clear reason, or have a history of recurring blood clots, or have a known condition that increases the risk of blood clot formation.Your "bad" cholesterol (LDL) is higher than 160 mg/dL and you have had a major heart-related event in the past year.You have very severe chronic kidney disease with a specific test showing a low kidney function.You have severe sleep apnea that hasn't been treated yet.You have had a leg bone break in the past year and want to participate in the LT+TRT group.Your bone density test shows that your bones are too weak.You are currently taking medication that prevents blood clotting and cannot receive injections in the muscle.You have used certain medications related to hormones or growth in the last 90 days.You have taken medications for bone health in the last 6 months.You have taken certain pain medications or steroids for more than a few days in the past week, unless you need them for a long-term condition.You have a spinal cord injury involving certain spinal segments and have been showing certain signs for more than 60 days.You have trouble walking at a regular speed, even with the help of devices or assistance.You have signs or symptoms related to low testosterone, such as reduced sexual desire, erectile dysfunction, decreased energy, or other related issues.You have a first-time spinal cord injury caused by trauma, vascular issues, or orthopedic problems.
Research Study Groups:
This trial has the following groups:- Group 1: testosterone enanthate
- Group 2: locomotor training, testosterone enanthate
- Group 3: non-interventional control
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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