What this study is
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.
What's being tested
- Tesamorelin 2 Milligrams (MG)
Intervention · DRUG
Daily self-administered study drug
Study details
- Official title
- Tesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy, and Improve Functional Outcomes Following Peripheral Nerve Injury
- Sponsor
- Johns Hopkins University
- Conditions
- Peripheral Nerve Injuries
- Enrolling
- 36 people
- Starts
- 2018-06-01
- Est. completion
- 2027-12
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Ulnar nerve laceration at the wrist, repaired primarily
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSami Tuffaha
Baltimore, Maryland, United States
- Ala Elhelali, PhD · Contact667-306-8861aelhela1@jhmi.edu
- Jaimie Shores, MD · Contact
- Sami H Tuffaha, MD · Principal investigator
- Jaimie T Shores, MD · Sub-investigator
- Ala Elhelali, PhD · Sub-investigator
- Ahmet Hoke, MD · Sub-investigator
- Roberto Salvatori, MD · Sub-investigator
- Shivani Ahlawat, MD · Sub-investigator
Recruiting
Study team
Sponsor
Johns Hopkins University
Study ID IRB00110936-2
Principal investigator
Sami Tuffaha, MD
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.