4-aminopyridine Treatment for Nerve Injury
Recruiting · NCT03701581 · Interventional (participants receive a specific treatment) · Lead sponsor: John Elfar
View the official record on ClinicalTrials.gov →Interventions studied
4-AminopyridinePlacebo
What this trial is about
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.
Who can take part
Age range
45 Years to 75 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 2 US states.
- University of Arizona - Tucson, Arizona, United States
- University of Rochester - Rochester, New York, United States