Using tesamorelin to help recovery after nerve injuries
Tesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy, and Improve Functional Outcomes Following Peripheral Nerve Injury
PHASE2 · Johns Hopkins University · NCT03150511
This study is testing if a medication called tesamorelin can help people recover better after surgery for nerve injuries, specifically those affecting the ulnar nerve.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03150511 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of tesamorelin in improving recovery outcomes for patients with peripheral nerve injuries, specifically focusing on ulnar nerve lacerations. Participants will be randomly assigned to receive either tesamorelin or no treatment after surgical repair of their nerve injury. The study will assess recovery through clinical exams, electrodiagnostic studies, and questionnaires over a 12-month period. The goal is to determine if tesamorelin can enhance nerve regeneration and functional recovery compared to the untreated group.
Who should consider this trial
Good fit: Ideal candidates are individuals with repaired ulnar nerve lacerations at the wrist.
Not a fit: Patients with certain cancers, uncontrolled diabetes or hypertension, or other specified health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to faster and more effective recovery of motor and sensory functions for patients with peripheral nerve injuries.
How similar studies have performed: While the use of tesamorelin for nerve injuries is a novel approach, previous studies have shown growth hormone's potential to improve nerve regeneration in animal models.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Sami Tuffaha — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Sami Tuffaha, MD — Johns Hopkins University
- Study coordinator: Sami Tuffaha, MD
- Email: stuffah1@jhmi.edu
- Phone: 410-614-4333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Nerve Injuries