4-aminopyridine Treatment for Nerve Injury

December 15, 2025 updated by: John Elfar

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
        • Contact:
        • Sub-Investigator:
          • Juan Chipollini, MD
        • Sub-Investigator:
          • John Elfar, MD
        • Contact:
        • Principal Investigator:
          • Rashid Sayyid, MD
        • Sub-Investigator:
          • Benjamin Lee, MD
    • New York
      • Rochester, New York, United States, 14602
        • Terminated
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Investigational Treatment
  • FDA-approved 10mg dalfampridine (generic Ampyra)
  • Subjects will not take more than 2 tablets in a 24-hour period
  • Subjects will take the tablets whole. They will not break, crush, chew, or dissolve tablets before swallowing.
  • The subjects will be told that the medication is released slowly over time and if the tablet is broken, the medicine may be released too fast which can raise the chance of having a seizure.
  • Study drug can be taken with or without food.
  • If a dose is missed they should not make up the missed dose. They will be told not to take two doses at the same time but to take the next dose at the regular scheduled time.
  • Subjects will be reminded not to take study drug together with other aminopyridine medications, including compounded 4-AP (sometimes called 4-aminopyridine or fampridine).
Drug: 4-Aminopyridine
FDA-approved tablets.
Other Names:
  • Fampridine
  • 4-AP
  • Dalfampridine
Placebo Comparator: Group B: Placebo
Subjects will receive an oral dose of placebo treatment the day after surgery, continuing daily for 2 months (60 days) following the same administration instructions as the investigational treatment. The placebo tablets will be manufactured by a licensed compounding pharmacy. The Investigational Drug Service at Banner University Medical Center will manage the placebos.
Other: Placebo
Placebo will be tooled to look similar to the study drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
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)
Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
Placebo vs. Active Drug Questionnaire
Time Frame: through study completion, an average of 1 year
Specific questions regarding patient blinding
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Diary
Time Frame: Daily for 90 days.
Subjects will record the time each day that they take the study drug/ placebo.
Daily for 90 days.
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
Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Elfar

Collaborators

University of Arizona

Investigators

  • Study Chair: John Elfar, MD, University of Arizona
  • Principal Investigator: Rashid Sayyid, MD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2021

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

October 8, 2018

First Posted (Actual)

October 10, 2018

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00003869

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At the conclusion of the study, de-identified patient outcomes will be provided with publication of results. This includes outcomes data as listed in the primary and secondary outcomes sections.

IPD Sharing Time Frame

For five years post study conclusion and publication.

IPD Sharing Access Criteria

Per the accepting journal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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