4-aminopyridine Treatment for Nerve Injury

Phase 2

Recruiting

• Conditions: Prostate Cancer; Nerve Injury
• Interventions: Drug: 4-Aminopyridine; Other: Placebo

• Registration Number: NCT03701581
• Lead Sponsor: John Elfar

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.

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 Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-10
• Study Start: 2021-06-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-07
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Investigational Treatment	4-Aminopyridine	* 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).
Group B: Placebo	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.

Primary Outcome Measures

Name	Time	Method
Michigan Incontinence Sympton Index (M-ISI) (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).	Incontinence measurement (change over time)
International Index of Erectile Function (IIEF) (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).	Erectile function measurement tool. (change over time)
Placebo vs. Active Drug Questionnaire	through study completion, an average of 1 year	Specific questions regarding patient blinding

Secondary Outcome Measures

Name	Time	Method
Drug Diary	Daily for 90 days.	Subjects will record the time each day that they take the study drug/ placebo.
Attempted Sexual Activity Questionnaire	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

Trial Locations

Locations (2)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Rochester; 🇺🇸 Rochester, New York, United States