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Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

NCT ID: NCT03150511

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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This is a randomized, double-blinded, clinical trial assessing the efficacy of tesamorelin as a therapy to improve functional recovery following peripheral nerve injury. Tesamorelin is a drug that stimulates increased production of growth hormone, and growth hormone has been shown to improve nerve regeneration and functional recovery in animal studies.

A total of 36 participants with repaired ulnar nerve lacerations will be enrolled, of which 18 will be randomly assigned to receive the study drug and 18 will receive no treatment. To minimize bias, outcome assessors and the biostatistician analyzing the data will be blinded to the treatment assignments. Following enrollment, each participant will have 12 monthly follow-up visits during which participants will undergo testing to assess recovery. Outcome assessments will include clinical exams, electrodiagnostic studies and questionnaires.

The total duration of the study is expected to be 4 years.

Conditions

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Peripheral Nerve Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tesamorelin treatment

Group Type EXPERIMENTAL

Tesamorelin 2 Milligrams (MG)

Intervention Type DRUG

Daily self-administered study drug

No Drug

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tesamorelin 2 Milligrams (MG)

Daily self-administered study drug

Intervention Type DRUG

Other Intervention Names

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Egrifta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sami Tuffaha, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Sami Tuffaha

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sami Tuffaha, MD

Role: CONTACT

Phone: 410-614-4333

Email: [email protected]

Facility Contacts

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Ala Elhelali, PhD

Role: primary

Jaimie Shores, MD

Role: backup

Other Identifiers

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W81XWH-16-C-0188

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W81XWH-22-1-0257

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00110936-2

Identifier Type: -

Identifier Source: org_study_id