4-aminopyridine Treatment for Nerve Injury
Status
RECRUITING
Phase
PHASE2, PHASE3
Age
45 - 75 Years
Enrollments
70Conditions
Nerve Injury, Prostate CancerDrugs
4-AminopyridineSummary
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.
Locations
1 location Found with status Recruiting
Eligibility 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
Study Plan
Group A: Investigational Treatment
EXPERIMENTAL
* FDA-approved 10mg dalfampridine (generic Ampyra)n* Subjects will not take more than 2 tablets in a 24-hour periodn* Subjects will take the tablets whole. They will not break, crush, chew, or dissolve tablets before swallowing.n* 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.n* Study drug can be taken with or without food.n* 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.n* 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-AminopyridineDescription:
FDA-approved tablets.
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:
PlaceboDescription:
Placebo will be tooled to look similar to the study drug.
Outcome Measures
Primary Outcome Measures
Michigan Incontinence Sympton Index (M-ISI) (change over time)
International Index of Erectile Function (IIEF) (change over time)
Placebo vs. Active Drug Questionnaire
Secondary Outcome Measures
Drug Diary
Attempted Sexual Activity Questionnaire
Timeline
Last Updated
May 4, 2025Start Date
October 10, 2018Today
December 7, 2025Completion Date ( Estimated )
December 1, 2028
Sponsors of this trial
Lead Sponsor
John Elfar
RECRUITING 
≥ 18 Years