4-Aminopyridine for Nerve Injury

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byBenjamin Lee, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: John Elfar

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

John Elfar, MD

Principal Investigator

University of Arizona

Benjamin Lee, MD

Principal Investigator

University of Arizona

Eligibility Criteria

Men aged 45-75 with early-stage, non-metastatic prostate cancer scheduled for nerve-sparing prostate surgery. They must have a PSA level under 15 ng/ml, no history of recurrent or advanced prostate cancer, and not need postoperative therapy. Participants should be sexually active with an erectile function score of at least 17 and cannot use other treatments for erectile dysfunction until three months after surgery.

Inclusion Criteria

I have been sexually active regularly for the last 6 months and in the 12 weeks before my prostate biopsy or surgery.

I am willing and able to give my consent to participate.

I am a man with early-stage prostate cancer planning to have a specific prostate surgery.

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Exclusion Criteria

I am scheduled for additional treatment after surgery for prostate cancer due to its advanced stage or spread.

My prostate cancer has spread beyond the prostate.

I am not taking any aminopyridine medications for any condition.

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Treatment Details

Interventions

4-Aminopyridine (Potassium Channel Blocker)

Trial OverviewThe trial is testing if the drug 4-aminopyridine can speed up recovery from nerve damage caused by traction or crush injuries during prostate surgery. Patients will either receive the actual drug or a placebo to compare outcomes.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group A: Investigational TreatmentExperimental Treatment1 Intervention

* 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 II: Group B: PlaceboPlacebo Group1 Intervention

Subjects will receive an oral dose of placebo treatment the day after surgery, continuing daily for 3 months (90 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. The placebo will be tooled to look similar to the investigational treatment using Coni-Snap #00 White/White (Opaque) capsules manufactured by Medisca and CapsOral filler manufactured by Specialized Rx.