4-aminopyridine Treatment for Nerve Injury

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

4-Aminopyridine

Placebo

About this trial

This is an interventional treatment trial for Nerve Injury focused on measuring prostatectomy, erectile dysfunction, prostate cancer, nerve injury, incontinence

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria

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

Exclusion Criteria

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
History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)
History of known hypersensitivity to 4AP
Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery
Renal impairment based on calculated GFR (GFR<60 mL/min)
Use of any other aminopyridine medications for any other indication

Sites / Locations

University of Rochester Department of UrologyRecruiting
University of Rochester Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A: Investigational Treatment

Group B: Placebo

Arm Description

4-Aminopyridine (FDA-approved drug) 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).

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 The University of Iowa Pharmaceuticals, 115 South Grand Avenue G-20, Iowa City, IA 52242. The Investigational Drug Service at the University of Rochester will manage the placebos. Placebo composition will include: 97% Microcrystalline Cellulose, NF (Avicel Ph 102) 2% Sodium Starch Glycolate, NF 1% Magnesium Stearate, NF The placebo will be covered in White Opadry, formulation OY-S-9603 and tooled to look similar to the investigational treatment.

Outcomes

Primary Outcome Measures

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

Incontinence measurement (change over time)

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

Erectile function measurement tool. (change over time)

University of Rochester Placebo vs. Active Drug Questionnaire

Specific questions regarding patient blinding

Secondary Outcome Measures

Drug Diary

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

University of Rochester Attempted Sexual Activity Questionnaire

Sexual activity assessment

Full Information

NCT ID

NCT03701581

First Posted

October 25, 2017

Last Updated

August 8, 2023

Sponsor

University of Rochester

Collaborators

Milton S. Hershey Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03701581

Brief Title

4-aminopyridine Treatment for Nerve Injury

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 5, 2021 (Actual)

Primary Completion Date

January 5, 2024 (Anticipated)

Study Completion Date

August 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nerve Injury, Prostate Cancer

Keywords

prostatectomy, erectile dysfunction, prostate cancer, nerve injury, incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Randomized placebo-controlled trial of 4AP vs placebo for nerve injury

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A: Investigational Treatment

Arm Type

Experimental

Arm Description

4-Aminopyridine (FDA-approved drug) 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).

Arm Title

Group B: Placebo

Arm Type

Placebo Comparator

Arm Description

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 The University of Iowa Pharmaceuticals, 115 South Grand Avenue G-20, Iowa City, IA 52242. The Investigational Drug Service at the University of Rochester will manage the placebos. Placebo composition will include: 97% Microcrystalline Cellulose, NF (Avicel Ph 102) 2% Sodium Starch Glycolate, NF 1% Magnesium Stearate, NF The placebo will be covered in White Opadry, formulation OY-S-9603 and tooled to look similar to the investigational treatment.

Intervention Type

Drug

Intervention Name(s)

4-Aminopyridine

Other Intervention Name(s)

4-AP, Fampridine

Intervention Description

FDA-approved tablets.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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).

Title

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

Description

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).

Title

University of Rochester Placebo vs. Active Drug Questionnaire

Description

Specific questions regarding patient blinding

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Drug Diary

Description

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

Time Frame

Daily for 90 days.

Title

University of Rochester Attempted Sexual Activity Questionnaire

Description

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).

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Restricted to male subjects due to the inclusion criteria of prostate cancer.

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria 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 Exclusion Criteria 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 History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater) History of known hypersensitivity to 4AP Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery Renal impairment based on calculated GFR (GFR<60 mL/min) Use of any other aminopyridine medications for any other indication

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Horne

Phone

717-531-7127

Email

ahorne@pennstatehealth.psu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ananya Das

Phone

7175314686

Email

adas1@pennstatehealth.psu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Ghazi, MD

Organizational Affiliation

University of Rochester, Department of Urology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John Elfar, MD

Organizational Affiliation

University of Rochester, and The Pennsylvania State University

Official's Role

Study Director

Facility Information:

Facility Name

University of Rochester Department of Urology

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Ghazi, MD

Phone

585-402-4868

Email

ahmed_ghazi@urmc.rochester.edu

First Name & Middle Initial & Last Name & Degree

Thomas L Osinski, MD

Phone

585-705-0247

Email

thomas_osinski@urmc.rochester.edu

First Name & Middle Initial & Last Name & Degree

John Elfar, MD

First Name & Middle Initial & Last Name & Degree

Ahmed Ghazi, MD

First Name & Middle Initial & Last Name & Degree

Edward Messing, MD

First Name & Middle Initial & Last Name & Degree

Mark Noble, PhD

First Name & Middle Initial & Last Name & Degree

Thomas L Osinski, MD

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Ghazi, MD

Phone

585-275-2838

Email

ahmed_ghazi@urmc.rochester.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

For five years post study conclusion and publication.

IPD Sharing Access Criteria

Per the accepting journal.

Nerve Injury, Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial