Peripheral Nerve InjuryPhase 1/2NCT00950391
Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus
A Phase 1/2 study testing Tacrolimus in people with Peripheral Nerve Injury, run by Washington University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Peripheral Nerve Injury
- What is being tested?
- Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Sep 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
About this study
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.
- Conditions
- Peripheral Nerve Injury
- Being tested
- Tacrolimus
- Keywords
- peripheral nerve injury, peripheral nerve surgery, nerve repair, nerve graft
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called FK506, Prograf
Tacrolimus 3 mg/day taken twice daily to maintain blood level of 3-6 ng/ml for duration of 1 year or less
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Experimental | Treatment with tacrolimus following nerve repair/reconstruction Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Recovery
Measured: 1-1.5 years
Incidence of adverse events.
Measured: 1 year
Secondary outcomes (2)
Recovery time.
Measured: 1.5 years
Recovery of sensation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startAug 2010
- Primary completionSep 2014 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: PI unable to secure funding for the project so study was not pursued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas H Tung, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950391
- Sponsor's protocol ID
- FK50600
- Status last verified
- Feb 2018
- First submitted
- 29 Jul 2009
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus
- ClinicalTrials.gov ID
- NCT00950391
- Acronym / sponsor ID
- FK50600
- Conditions
- Peripheral Nerve Injury
- Keywords
- peripheral nerve injury, peripheral nerve surgery, nerve repair, nerve graft
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI unable to secure funding for the project so study was not pursued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | Experimental | Drug: TacrolimusTreatment with tacrolimus following nerve repair/reconstruction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusAlso: FK506, PrografTacrolimus 3 mg/day taken twice daily to maintain blood level of 3-6 ng/ml for duration of 1 year or less | Drug | Tacrolimus |
Primary outcome
Functional Recovery
Time frame: 1-1.5 years
Incidence of adverse events.
Time frame: 1 year
2 secondary outcomes
Recovery time.
Time frame: 1.5 years
Recovery of sensation.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas H Tung, MD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tacrolimus in people with Peripheral Nerve Injury, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Recovery (time frame: 1-1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.