Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03150511
Phase
PHASE2
Status
Recruiting
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Conditions

  • Peripheral Nerve Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tesamorelin 2 Milligrams (MG) — DRUG
    Daily self-administered study drug

Study Details

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.

Key Dates

Start date
Jun 1, 2018
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tesamorelin treatment
  • No Intervention: No Drug

Primary Outcome Measure

3-point chuck pinch test [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sami TuffahaBaltimoreMaryland21205
Ala Elhelali, PhD
[email protected]
667-306-8861
Jaimie Shores, MD
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)

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