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Potassium Channel Blocker

4-Aminopyridine for Nerve Injury

Phase 2 & 3

Waitlist Available

Led By Benjamin Lee, MD

Research Sponsored by John Elfar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Summary

This trial is testing whether 4-aminopyridine can speed up the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with similar medications include skin irritation, dizziness, nausea, and potential allergic reactions. People sensitive to this type of medication or those with kidney issues are excluded.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My PSA level is under 15, and I won't need further treatment after surgery.

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I am between 45 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My prostate cancer has spread beyond the prostate.

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I am not taking any aminopyridine medications for any condition.

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My prostate cancer has come back after treatment.

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I have a history of seizures, multiple sclerosis, stroke, or another neurological disorder.

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My kidney function is reduced.

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I have had penile surgery, but only for circumcision or urethral issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

International Index of Erectile Function (IIEF) (change over time)

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

Placebo vs. Active Drug Questionnaire

Secondary study objectives

Attempted Sexual Activity Questionnaire

Drug Diary

Trial Design

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.

0 / 10Eligibility criteria met