Peripheral Nerve Injury Clinical Trial
Official title:
Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02359825 -
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
|
Phase 1 | |
| Not yet recruiting |
NCT02865317 -
Cortical Effects of Peripheral Nerve Injury At Birth
|
N/A | |
| Recruiting |
NCT01554722 -
Needle Nerve Contact in Ultrasound Guided Femoral Block
|
N/A | |
| Recruiting |
NCT06071988 -
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy
|
Phase 3 | |
| Recruiting |
NCT06071936 -
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy
|
Phase 3 | |
| Recruiting |
NCT05541250 -
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
|
Phase 1 | |
| Recruiting |
NCT06209632 -
Mirror Therapy Combined With Contralaterally Controlled Functional Electrical Stimulation for Peripheral Nerve Injury
|
N/A | |
| Completed |
NCT01116362 -
Comparing Primary With Secondary Repair of Based on Electrodiagnostic Assessment and Clinical Examination
|
Phase 2 | |
| Withdrawn |
NCT04270019 -
Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration
|
Phase 1/Phase 2 | |
| Completed |
NCT01302275 -
Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain
|
Phase 4 | |
| Terminated |
NCT01088256 -
Efficacy of Etoricoxib on Peripheral Hyperalgesia
|
Phase 2 | |
| Completed |
NCT02228928 -
Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain
|
Phase 1/Phase 2 | |
| Completed |
NCT00953277 -
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
|
Phase 4 | |
| Not yet recruiting |
NCT06003166 -
4-AP Peripheral Nerve Crossover Trial
|
Phase 3 | |
| Not yet recruiting |
NCT02666456 -
The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain
|
N/A | |
| Not yet recruiting |
NCT02352649 -
Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Peripheral Nerve Injury
|
Phase 1/Phase 2 | |
| Terminated |
NCT02034461 -
Micro-Electrodes Implanted in a Human Nerve
|
N/A | |
| Completed |
NCT01596491 -
Study of Possible Changes in QST After Application of Capsaicin on Patients With Peripheral Neuropathic Pain
|
N/A | |
| Recruiting |
NCT03147313 -
Extracorporal Shock Wave Treatment to Improve Nerve Regeneration
|
N/A |