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Locomotor Training + Testosterone for Spinal Cord Injury

Phase 2
Recruiting
Led By Joshua F Yarrow, 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
Men >18 years of age
Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs (i.e., spasticity, hypertonicity) for >60-days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months, 6 months
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Men who are older than 18 years.
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You have a spinal cord injury involving certain spinal segments and have been showing certain signs for more than 60 days.
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You have signs or symptoms related to low testosterone, such as reduced sexual desire, erectile dysfunction, decreased energy, or other related issues.
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You have trouble walking at a regular speed, even with the help of devices or assistance.
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You have a first-time spinal cord injury caused by trauma, vascular issues, or orthopedic problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, 6 months for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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

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
12 Previous Clinical Trials
1,675 Total Patients Enrolled

Media Library

Locomotor Training Clinical Trial Eligibility Overview. Trial Name: NCT04460872 — Phase 2
Low Testosterone Research Study Groups: testosterone enanthate, locomotor training, testosterone enanthate, non-interventional control
Low Testosterone Clinical Trial 2023: Locomotor Training Highlights & Side Effects. Trial Name: NCT04460872 — Phase 2
Locomotor Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04460872 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for participants in this trial?

"The information available on clinicaltrials.gov verifies that this study is still seeking patients for participation. The listing was created on 1/31/2021, with the most recent update taking place on 9/26/2022. Two medical facilities are looking to enrol a total of 21 individuals."

Answered by AI

How many people are included in this medical study?

"Yes, you're right. The clinical trial aforementioned is looking for 21 individuals from 2 sites. The listing was created on 1/31/2021 and updated as recently as 9/26/2022 according to information found on clinicaltrials.gov"

Answered by AI

Is Locomotor Training a safe way for people to get around?

"Locomotor Training received a 2 on our team's safety scale at Power. This is because, while there are Phase 2 trials supporting the intervention's safety, there is no data currently backing up its efficacy."

Answered by AI

What are the researchers' goals for this clinical trial?

"The primary outcome being tracked in this medical study is a change in the 6 min walk test (6MWT) score, with observations taking place at the start of the trial and then 3 and 6 months later. Additionally, researchers will be looking for changes in 10mWT time, bone resorption marker levels, and knee extensor peak torque as secondary outcomes over the course of the clinical trial."

Answered by AI

Are there previous examples of Locomotor Training being used in a medical capacity?

"There are six separate clinical trials currently underway to research locomotor training. Of these, none have reached phase 3 yet. The majority of the studies are taking place in Galveston, Texas; however, there are seven research centres in total running these tests."

Answered by AI
~5 spots leftby Feb 2025