4-aminopyridine Treatment for Nerve Injury

NCT03701581 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 00003869
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  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)

  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

  Specific questions regarding patient blinding

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Drug Diary

  Daily for 90 days.

• 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).

Study Arms (2)

Group A: Investigational Treatment

EXPERIMENTAL

* 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

Group B: Placebo

PLACEBO COMPARATOR

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

Interventions

4-Aminopyridine DRUG

FDA-approved tablets.

Also known as: 4-AP, Fampridine, Dalfampridine

Group A: Investigational Treatment

Placebo OTHER

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

Group B: Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Restricted to male subjects due to the inclusion criteria of prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John Elfar: lead

Study Sites (2)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

University of Rochester

Rochester, New York, 14602, United States

TERMINATED

Related Publications (1)

• Ghazi A, Osinski TL, Feng C, Horne A, Elfar J. 4-Aminopyridine treatment for nerve injury resulting from radical retro-pubic prostatectomy: a single-center double-blind, randomized, placebo-controlled study. Trials. 2024 May 21;25(1):332. doi: 10.1186/s13063-024-08102-z.

  PMID: 38773595 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rashid Sayyid, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• John Elfar, MD

  University of Arizona

  STUDY CHAIR

Central Study Contacts

Andrea Horne

CONTACT

520-626-6456; ahh@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tenured Professor, Chairman, Department of Orthopaedic Surgery

Model Details: Randomized placebo-controlled trial of 4AP vs placebo for nerve injury

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 10, 2018
• Study Start: June 5, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: For five years post study conclusion and publication.
• Access Criteria: Per the accepting journal.

Locations

US (2)