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Led by John Elfar · Updated on 2025-12-17
70
Participants Needed
2
Research Sites
74 weeks
Total Duration
Researchers are studying the potential effects of 4-aminopyridine 4-AP on recovery after peripheral nerve injuries caused by traction or crush. The study focuses on men with prostate cancer undergoing robot-assisted radical prostatectomy, as nerve injury during this surgery may lead to erectile dysfunction and urinary continence issues. This research aims to test whether 4-AP can speed up the often slow and unpredictable recovery process after such nerve injuries. Participants will receive either FDA-approved 10 mg 4-aminopyridine tablets or placebo tablets after surgery. The medication is taken orally, with a maximum of two tablets per 24 hours, and must be swallowed whole without breaking or crushing. The treatment period lasts for 60 days following surgery. The placebo is designed to look like the active drug, and participants will be reminded not to take other aminopyridine medications during the study. Throughout the study, participants will be monitored for changes in urinary incontinence and erectile function using standardized questionnaires every seven days for six months. They will also keep a daily drug diary for 90 days and complete sexual activity questionnaires regularly. The study includes follow-up for up to one year to assess recovery progress and safety. The total participation time involves regular assessments and monitoring after the surgery.
CONDITIONS
4-aminopyridine Treatment for Nerve Injury
A
Andrea Horne
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John Elfar
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | 4‑Aminopyridine (investigational) | Placebo (trial control) | PDE5 inhibitors (standard care) |
|---|---|---|---|
| What it is | Oral 4‑Aminopyridine tablets under investigation to improve erectile and urinary function after nerve‑sparing prostatectomy | Matched placebo tablets used as control | Oral PDE5 inhibitors such as sildenafil or tadalafil are the common first‑line treatment for erectile dysfunction after nerve‑sparing prostatectomy |
| Role in trial | Experimental treatment being tested | Control arm receiving placebo | Represents non‑trial current treatment pathway for context |
| Primary use | To improve recovery of erectile and urinary function post‑nerve‑sparing surgery | To serve as control for assessing investigational drug effects | To help restore erectile function after prostatectomy in routine clinical care |
| How it is given or performed | Oral tablets | Oral matched placebo tablets | Given as oral tablets such as sildenafil or tadalafil as prescribed in standard clinical context |
| Evidence status | Effectiveness under investigation; results pending | No therapeutic effect expected; serves to support efficacy assessment | Substantial evidence supports their efficacy in improving erectile function post‑nerve‑sparing prostatectomy |
| Important risks | Safety profile for this indication is under study and not yet established | Minimal risk expected since placebo contains no active drug | PDE5 inhibitors are generally well tolerated but may cause headaches, flushing, or low blood pressure, as recognized in clinical use |
| Important limitations | Benefit over placebo is not yet known; applicability limited to patients similar to trial eligibility | Not a treatment; does not reflect standard care effect | While commonly used, not all patients respond and some may require alternative therapies |
| Patient impact | Unknown; trial results needed to assess impact on quality of life or functional outcomes | No direct benefit; supports trial evaluation only | Often improves erections and sexual function in many men post‑prostatectomy, enhancing sexual activity potential |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 months (60 days)
Participants receive either 4-aminopyridine or placebo daily starting the day after surgery, continuing for 2 months (60 days).
Daily dosing throughout treatment period
Duration - 6 months
Participants are monitored with questionnaires and assessments starting 7 days after surgery and continuing weekly for 6 months to evaluate recovery and symptoms.
Weekly visits for up to 6 months (up to 25 visits)
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Ahmed Ghazi, Thomas L Osinski, Changyong Feng...
https://pubmed.ncbi.nlm.nih.gov/38773595/John Elfar
Lead Sponsor
