4-aminopyridine Treatment for Nerve Injury

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified November 2025 by John Elfar
Sponsor
John Elfar
Information Provided by (Responsible Party)
John Elfar
Clinicaltrials.gov Identifier
NCT03701581
Other Study ID Numbers:
00003869
First Submitted
October 24, 2017
First Posted
October 9, 2018
Last Update Posted
December 16, 2025
Last Verified
November 2025

ClinicalTrials.gov processed this data on December 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Nerve InjuryProstate Cancer
Drug: 4-AminopyridineOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment70 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official Title4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy
Study Start DateJune 4, 2021
Actual Primary Completion Date1yr 3w from now
Actual Study Completion Date2yrs 5mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures
  1. Michigan Incontinence Sympton Index (M-ISI) (change over time)
    Incontinence measurement (change over time)
  2. International Index of Erectile Function (IIEF) (change over time)
    Erectile function measurement tool. (change over time)
  3. Placebo vs. Active Drug Questionnaire
    Specific questions regarding patient blinding
Secondary Outcome Measures
  1. Drug Diary
    Subjects will record the time each day that they take the study drug/ placebo.
  2. Attempted Sexual Activity Questionnaire
    Sexual activity assessment

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyMale
Accepts Healthy VolunteersNo
Inclusion 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
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

Contacts and Locations

Sponsors and CollaboratorsJohn Elfar
Locations
University of Arizona | Tucson Arizona, United States, 85724University of Rochester | Rochester New York, United States, 14602
Investigators
Principal Investigator: Rashid Sayyid, MD, University of ArizonaStudy Chair: John Elfar, MD, University of Arizona