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NCT Number: NCT03701581

4-aminopyridine Treatment for Nerve Injury

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.

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Key information

Conditions

Nerve Injury Erectile Dysfunction Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Urogenital Neoplasms

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Arizona, Tucson, Arizona, United States

Loading trial locations.

About this study

To evaluate the role of 4-AP on the recovery of nerve function we will be giving patients with prostate cancer who are undergoing robot assisted radical prostatectomy (RP) either 4-AP or placebo in the perioperative period. This population of patients was selected as nerve crush injury during RP is thought to contribute to erectile dysfunction and urinary continence post operatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4-aminopyridine

Drug

FDA-approved tablets.

Other names: 4-AP, Fampridine, Dalfampridine

Placebo

Other

Placebo will be tooled to look similar to the study drug.

Primary outcomes

  1. Michigan Incontinence Sympton Index (M-ISI) (change over time)

    Time frame: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).

    Incontinence measurement (change over time)

  2. International Index of Erectile Function (IIEF) (change over time)

    Time frame: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).

    Erectile function measurement tool. (change over time)

  3. Placebo vs. Active Drug Questionnaire

    Time frame: through study completion, an average of 1 year

    Specific questions regarding patient blinding

Secondary outcomes

  1. Drug Diary

    Time frame: Daily for 90 days.

    Subjects will record the time each day that they take the study drug/ placebo.

  2. Attempted Sexual Activity Questionnaire

    Time frame: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).

    Sexual activity assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Horne

CONTACT

[email protected]

520-626-6456

Sponsors and collaborators

Lead sponsor

John Elfar

Other

Registry information

Official study title

4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Oct 10, 2018
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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