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Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus

This study is not yet open for participant recruitment.
Verified January 2010 by Washington University School of Medicine
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00950391
First received: July 29, 2009
Last updated: January 11, 2010
Last verified: January 2010
History of Changes
  Purpose

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:

  1. 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;
  2. Correlate the quality of life outcome with assessment of functional recovery after surgical reconstruction of patients with severe peripheral nerve injuries of the extremities.

Condition Intervention Phase
Peripheral Nerve Injury
 Drug: Tacrolimus
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Functional Recovery [ Time Frame: 1-1.5 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recovery time. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Recovery of sensation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus
Treatment with tacrolimus following nerve repair/reconstruction
 Drug: Tacrolimus
Tacrolimus 3 mg/day taken twice daily to maintain blood level of 3-6 ng/ml for duration of 1 year or less
Other Name: FK506, Prograf

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. positive HIV or hepatitis blood test
  2. recent history of cancer within the past 5 years
  3. history of severe and recurrent infections (such as hidradenitis suppurativa)
  4. presence of ongoing and unresolved infectious concerns related to original injury or previous surgery (such as osteomyelitis, wound infection) or otherwise
  5. presence of ongoing wound healing problems related to the injury or previous surgery or otherwise
  6. 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)
  7. creatinine level ≥ 1.0 mg/dl or more than ULN
  8. hemoglobin value of <9.0 mg/dl, a white blood cell count <3,000 cells/mm3, or platelet count <100,000 platelets/mm3
  9. uncontrolled hypertension with systolic blood pressure >160 mm Hg and diastolic blood pressure >90 mm Hg at screening and baseline
  10. hyperkalemia (serum K > ULN)
  11. pancreatitis or diabetes mellitus (fasting blood sugar ≥ 110 mg/dl or postprandial blood sugar ≥ 160 mg/dl) or a history of these
  12. heart disease or abnormal electrocardiogram (ECG) especially arrhythmia and change in ST/T or a previous history of these
  13. history of serious drug hypersensitivity
  14. age less than 18 or greater than 50
  15. 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950391

Contacts
Contact: Thomas H Tung, MD (314) 362-4588 tungt@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Thoomas H Tung, MD     314-362-4588     tungt@wustl.edu    
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Thomas H Tung, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Thomas Tung, Washington University
ClinicalTrials.gov Identifier: NCT00950391     History of Changes
Other Study ID Numbers: FK50600
Study First Received: July 29, 2009
Last Updated: January 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
peripheral nerve injury
peripheral nerve surgery
nerve repair
nerve graft

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013