Health TrialsbyHealthPanel

4-aminopyridine Treatment for Nerve Injury

ConditionsNerve InjuryProstate Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age45-75
SponsorJohn Elfar

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 4-Aminopyridine

    Drug

    FDA-approved tablets.

  • Placebo

    Other intervention

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Group A: Investigational TreatmentExperimental treatment 1 intervention
Group B: Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Incontinence measurement (change over time)

Time frame
Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
2

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

Erectile function measurement tool. (change over time)

Time frame
Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
3

Placebo vs. Active Drug Questionnaire

Specific questions regarding patient blinding

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Drug Diary

Subjects will record the time each day that they take the study drug/ placebo.

Time frame
Daily for 90 days.
2

Attempted Sexual Activity Questionnaire

Sexual activity assessment

Time frame
Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John Elfar

Lead sponsor

University of Arizona

Sponsor institution

Source ClinicalTrials.gov
Apply now