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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Investigational Treatment | Experimental |
|
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-Aminopyridine | Drug | FDA-approved tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Michigan Incontinence Sympton Index (M-ISI) (change over time) | Incontinence measurement (change over time) | Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times). |
| International Index of Erectile Function (IIEF) (change over time) | Erectile function measurement tool. (change over time) | Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times). |
| Placebo vs. Active Drug Questionnaire | Specific questions regarding patient blinding | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Diary | Subjects will record the time each day that they take the study drug/ placebo. | Daily for 90 days. |
| Attempted Sexual Activity Questionnaire | Sexual activity assessment |
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Inclusion Criteria
Exclusion Criteria
Restricted to male subjects due to the inclusion criteria of prostate cancer.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Horne | Contact | 520-626-6456 | ahh@arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rashid Sayyid, MD | University of Arizona | Principal Investigator |
| John Elfar, MD | University of Arizona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38773595 | Derived | Ghazi A, Osinski TL, Feng C, Horne A, Elfar J. 4-Aminopyridine treatment for nerve injury resulting from radical retro-pubic prostatectomy: a single-center double-blind, randomized, placebo-controlled study. Trials. 2024 May 21;25(1):332. doi: 10.1186/s13063-024-08102-z. |
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At the conclusion of the study, de-identified patient outcomes will be provided with publication of results. This includes outcomes data as listed in the primary and secondary outcomes sections.
For five years post study conclusion and publication.
Per the accepting journal.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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Randomized placebo-controlled trial of 4AP vs placebo for nerve injury
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| Placebo | Other | Placebo will be tooled to look similar to the study drug. |
|
| Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times). |
| University of Rochester | Terminated | Rochester | New York | 14602 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |