Recruiting
Phase 2
Phase 3

4-Aminopyridine

Sponsor:

John Elfar

Code:

NCT03701581

Conditions

Nerve Injury

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

4-Aminopyridine

Placebo

Study Details

Brief summary:

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.

Conditions

Nerve Injury

Prostate Cancer

Study ID

NCT03701581

Start date

Jun 5, 2021

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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.

Interventions

4-Aminopyridine

FDA-approved tablets.

Placebo

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

Primary outcome measure

  • 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). ]
  • 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). ]
  • Placebo vs. Active Drug Questionnaire [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Andrea Horne

520-626-6456ahh@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

John Elfar, MD

elfar@arizona.edu

Carly J Deal

520-626-6456carlyjdeal@arizona.edu

Principal Investigator:

Rashid Sayyid, MD

More Information

Sponsor

John Elfar

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • prostatectomy
  • erectile dysfunction
  • prostate cancer
  • nerve injury
  • incontinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by John Elfar on 2025-12-17.