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Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus

Primary Purpose

Peripheral Nerve Injury

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Tacrolimus

About this trial

This is an interventional treatment trial for Peripheral Nerve Injury focused on measuring peripheral nerve injury, peripheral nerve surgery, nerve repair, nerve graft

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

have deficit of upper extremity function of MRC grade 0-2
are candidates for surgical reconstruction
are no more than 10 months after their injury
have no ongoing infectious or wound healing complications related to injury or previous surgery or otherwise
have no history of cancer or have been treated and free of cancer for at least 5 years
age 18-50
agree to participate in the study

Exclusion Criteria:

positive HIV or hepatitis blood test
recent history of cancer within the past 5 years
history of severe and recurrent infections (such as hidradenitis suppurativa)
presence of ongoing and unresolved infectious concerns related to original injury or previous surgery (such as osteomyelitis, wound infection) or otherwise
presence of ongoing wound healing problems related to the injury or previous surgery or otherwise
presence of moderate or severe liver disease as indicated by aspartate transaminase (AST), alanine transaminase (ALT), amino alkaline phosphatase, or total bilirubin levels greater than the upper limit of normal (ULN)
creatinine level ≥ 1.0 mg/dl or more than ULN
hemoglobin value of <9.0 mg/dl, a white blood cell count <3,000 cells/mm3, or platelet count <100,000 platelets/mm3
uncontrolled hypertension with systolic blood pressure >160 mm Hg and diastolic blood pressure >90 mm Hg at screening and baseline
hyperkalemia (serum K > ULN)
pancreatitis or diabetes mellitus (fasting blood sugar ≥ 110 mg/dl or postprandial blood sugar ≥ 160 mg/dl) or a history of these
heart disease or abnormal electrocardiogram (ECG) especially arrhythmia and change in ST/T or a previous history of these
history of serious drug hypersensitivity
age less than 18 or greater than 50
incarceration prior to or at the time of consideration for enrollment (any participant who becomes incarcerated during the course of the study will be excluded)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tacrolimus

Arm Description

Treatment with tacrolimus following nerve repair/reconstruction

Outcomes

Primary Outcome Measures

Functional Recovery

Incidence of adverse events.

Secondary Outcome Measures

Recovery time.

Recovery of sensation.

Full Information

NCT ID

NCT00950391

First Posted

July 29, 2009

Last Updated

February 9, 2018

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00950391

Brief Title

Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus

Official Title

Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Withdrawn

Why Stopped

PI unable to secure funding for the project so study was not pursued.

Study Start Date

August 2010 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Tacrolimus (FK506) is an immunosuppressive medication that promotes organ allograft survival. It has also been shown to enhance nerve regeneration and muscle reinnervation in animals but these properties have not previously been studied in patients. Moreover, currently there is no method in clinical use to speed the rate of recovery after nerve injury. The objective of this study is to explore the ability of tacrolimus to benefit the treatment of patients with peripheral nerve injury. To minimize the morbidity of tacrolimus therapy, its phase-specific effects on nerve regeneration and muscle reinnervation will be defined in the murine model to permit further limitation of the duration of therapy. The investigators hypothesize that treatment with tacrolimus after autogenous peripheral nerve reconstruction will accelerate nerve regeneration, reduce the period of denervation and improve muscle reinnervation and recovery in patients with peripheral nerve injury. There are 2 specific aims: Determine the safety and efficacy of tacrolimus following reconstructive nerve surgery in a double-blind placebo-controlled randomized pilot clinical trial of patients with severe nerve injuries of the extremities; Correlate the quality of life outcome with assessment of functional recovery after surgical reconstruction of patients with severe peripheral nerve injuries of the extremities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Nerve Injury

Keywords

peripheral nerve injury, peripheral nerve surgery, nerve repair, nerve graft

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tacrolimus

Arm Type

Experimental

Arm Description

Treatment with tacrolimus following nerve repair/reconstruction

Intervention Type

Drug

Intervention Name(s)

Tacrolimus

Other Intervention Name(s)

FK506, Prograf

Intervention Description

Tacrolimus 3 mg/day taken twice daily to maintain blood level of 3-6 ng/ml for duration of 1 year or less

Primary Outcome Measure Information:

Title

Functional Recovery

Time Frame

1-1.5 years

Title

Incidence of adverse events.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Recovery time.

Time Frame

1.5 years

Title

Recovery of sensation.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: have deficit of upper extremity function of MRC grade 0-2 are candidates for surgical reconstruction are no more than 10 months after their injury have no ongoing infectious or wound healing complications related to injury or previous surgery or otherwise have no history of cancer or have been treated and free of cancer for at least 5 years age 18-50 agree to participate in the study Exclusion Criteria: positive HIV or hepatitis blood test recent history of cancer within the past 5 years history of severe and recurrent infections (such as hidradenitis suppurativa) presence of ongoing and unresolved infectious concerns related to original injury or previous surgery (such as osteomyelitis, wound infection) or otherwise presence of ongoing wound healing problems related to the injury or previous surgery or otherwise presence of moderate or severe liver disease as indicated by aspartate transaminase (AST), alanine transaminase (ALT), amino alkaline phosphatase, or total bilirubin levels greater than the upper limit of normal (ULN) creatinine level ≥ 1.0 mg/dl or more than ULN hemoglobin value of <9.0 mg/dl, a white blood cell count <3,000 cells/mm3, or platelet count <100,000 platelets/mm3 uncontrolled hypertension with systolic blood pressure >160 mm Hg and diastolic blood pressure >90 mm Hg at screening and baseline hyperkalemia (serum K > ULN) pancreatitis or diabetes mellitus (fasting blood sugar ≥ 110 mg/dl or postprandial blood sugar ≥ 160 mg/dl) or a history of these heart disease or abnormal electrocardiogram (ECG) especially arrhythmia and change in ST/T or a previous history of these history of serious drug hypersensitivity age less than 18 or greater than 50 incarceration prior to or at the time of consideration for enrollment (any participant who becomes incarcerated during the course of the study will be excluded)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas H Tung, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus

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