Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
Tesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy, and Improve Functional Outcomes Following Peripheral Nerve Injury
3 other identifiers
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
November 12, 2025
November 1, 2025
9.5 years
April 19, 2017
November 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
3-point chuck pinch test
Pinch strength measure as measured by a pinch gauge.
12 months
Secondary Outcomes (7)
Disability of the Arm, Shoulder, and Hand (DASH) score
12 months
Michigan Hand Questionnaire score
12 months
Amplitude of response
12 months
Latency of response
12 months
Velocity of response
12 months
- +2 more secondary outcomes
Study Arms (2)
Tesamorelin treatment
EXPERIMENTALNo Drug
NO INTERVENTIONInterventions
Daily self-administered study drug
Eligibility Criteria
You may qualify if:
- Ulnar nerve laceration at the wrist, repaired primarily
You may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- United States Department of Defensecollaborator
Study Sites (1)
Sami Tuffaha
Baltimore, Maryland, 21205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sami Tuffaha, MD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2017
First Posted
May 12, 2017
Study Start
June 1, 2018
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
November 12, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share