Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
-
- STATUS
- Recruiting
-
- End date
- Dec 18, 2023
-
- participants needed
- 36
-
- sponsor
- Johns Hopkins University
Summary
The aim of this clinical trial is to assess the efficacy of tesamorelin as a therapy for peripheral nerve injuries. The investigators hypothesize that treatment with tesamorelin will allow for faster and greater recovery of motor and sensory function following surgical repair of injured peripheral nerves. Patients with upper extremity nerve injuries will be randomly assigned to receive either the drug or a placebo (inactive drug). A number of tests for nerve regeneration, muscle function and sensation will be performed every month for a total of 12 months. Outcomes in the patients treated with tesamorelin will be compared to outcomes in patients who received the placebo to determine the effectiveness of tesamorelin as a therapy for nerve injuries.
Description
This is a multi-institutional, randomized, double-blinded, placebo-controlled clinical trial assessing the efficacy of tesamorelin as a therapy to improve functional recovery following peripheral nerve injury. Tesamorelin is a drug that stimulates increased production of growth hormone, and growth hormone has been shown to improve nerve regeneration and functional recovery in animal studies. A total of 36 participants with repaired ulnar nerve lacerations will be enrolled, of which 18 will be randomly assigned to receive the study drug and 18 will receive the placebo. To avoid bias, the study participants and investigators will be blinded to the treatment group assignments. Following enrollment, each participant will have 12 monthly follow-up visits during which participants will undergo testing to assess recovery. Outcome assessments will include clinical exams, MRI, electrodiagnostic studies and questionnaires. The total duration of the study is expected to be 4 years.
Details
| Condition | Peripheral Nerve Injuries |
|---|---|
| Treatment | Placebo, Tesamorelin 2 Milligrams (MG) |
| Clinical Study Identifier | NCT03150511 |
| Sponsor | Johns Hopkins University |
| Last Modified on | 5 March 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer