4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Other, Drug

Study Type: Interventional

Study Phase: Phase 2/Phase 3

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.

Eligibility

Participation Requirements

Sex: Male

Minimum Age: 45

Maximum Age: 75

Healthy Volunteers: f

View:

• 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

Locations

United States

Arizona

University of Arizona

RECRUITING

Tucson

New York

University of Rochester

TERMINATED

Rochester

Contact Information

Primary

Andrea Horne

ahh@arizona.edu

520-626-6456

Time Frame

Start Date: 2021-06-05

Estimated Completion Date: 2028-12

Participants

Target number of participants: 70

Treatments

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.

Authors

Ahmed Ghazi, Mark Noble, Edward Messing, Thomas L Osinski

Related Therapeutic Areas

Prostate Cancer

Prostatectomy

Erectile Dysfunction (ED)

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4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy

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