4-aminopyridine Treatment for Nerve Injury

• Status: Recruiting
• Trial end date: 2025-08-05
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and/or crush injury. This study aims to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center; University of Rochester
• Collaborators: Milton S. Hershey Medical Center; University of Rochester
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria

• Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c), planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve Sparing Radical Prostatectomy (NSRP)

• Prostate-Specific Antigen (PSA) levels less than 15 ng/ml (within the last 12 months), with biopsy-proven prostate cancer, for whom postoperative adjuvant therapy (e.g. radiation or androgen deprivation therapy) is not expected to be needed

• Ages 45-75

• An Abridged International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening

• Has experienced at least 6 months of regular sexual activity and sexual activity during the 12 weeks prior to prostate biopsy or surgery

• Willingness to abstain from treatments for Erectile Dysfunction until 3 months after surgery

• Willingness to participate and able to provide informed consent

Exclusion Criteria

• Planned adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater), positive lymph nodes or positive surgical margins

• Neo-adjuvant therapy prior to NSRP

• History of recurrent prostate cancer

• History of seizures, multiple sclerosis, stroke or any other diagnosed neurological disorder

• History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)

• History of known hypersensitivity to 4AP

• Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery

• Renal impairment based on calculated GFR (GFR<60 mL/min)

• Use of any other aminopyridine medications for any other indication