NCT03150511 Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
| NCT ID | NCT03150511 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins University |
| Condition | Peripheral Nerve Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2018-06-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2018-06-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this clinical trial is to evaluate the efficacy of tesamorelin as a therapy for peripheral nerve injuries. The investigators hypothesize that treatment with tesamorelin will result in faster and more substantial 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 tesamorelin treatment or no treatment. Assessments for nerve regeneration, muscle function, and sensation will be conducted every three months for a total of 12 months. Outcomes in patients receiving tesamorelin will be compared to those in the untreated group to determine the effectiveness of tesamorelin as a therapeutic intervention for nerve injuries.
Eligibility Criteria
Inclusion Criteria: * Ulnar nerve laceration at the wrist, repaired primarily Exclusion Criteria: * Certain cancers (active or in the past) * Uncontrolled diabetes or hypertension * Certain pituitary problems * Oral contraceptives * Pregnancy * Drug or alcohol dependence * Psychosocial issues that would limit participation and compliance
Contact & Investigator
Sami Tuffaha, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT03150511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Nerve Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03150511 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03150511 currently recruiting?
Yes, NCT03150511 is actively recruiting participants. Contact the research team at stuffah1@jhmi.edu for enrollment information.
Where is the NCT03150511 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03150511 clinical trial?
NCT03150511 is sponsored by Johns Hopkins University. The principal investigator is Sami Tuffaha, MD at Johns Hopkins University. The trial plans to enroll 36 participants.