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4-aminopyridine Treatment for Nerve Injury

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ClinicalTrials.gov Identifier: NCT03701581
Recruitment Status : Not yet recruiting
First Posted : October 10, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
John Elfar, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 4-Aminopyridine Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: 4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A: Investigational Treatment
  • 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).
Drug: 4-Aminopyridine
FDA-approved tablets.
Other Names:
  • 4-AP
  • Fampridine

Placebo Comparator: Group B: Placebo

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.

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




Primary Outcome Measures :
  1. Michigan Incontinence Sympton Index (M-ISI) (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). ]
    Incontinence measurement (change over time)

  2. International Index of Erectile Function (IIEF) (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). ]
    Erectile function measurement tool. (change over time)


Secondary Outcome Measures :
  1. Drug Diary [ Time Frame: Daily for 90 days. ]
    Subjects will record the time each day that they take the study drug/ placebo.

  2. Creatinine level (change over time) [ Time Frame: Pre-operative visit, and every fourteen days (first measurement is post operative day one and then measurements will be made every 14 days, 14 days post-op, 28 days post-op, etc ) for 2 months (up to 4 times). ]
    Creatinine level (change over time)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Restricted to male subjects due to the inclusion criteria of prostate cancer.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients with organ-confined, non-metastatic prostate cancer (stages CT1c-T2c)
  • Prostate-specific antigen (PSA) levels less than 10 ng/ml; a Gleason score less than or equal to 8 (prostate biopsy-proven)
  • Ages 45-70
  • Undergoing Robotic-assisted Laparoscopic Nerve sparing radical prostatectomy (NSRP) for biopsy-proven prostate cancer
  • An International Index of Erectile Function- Erectile Function greater than 18 at time of screening (after cancer diagnosis, and greater than 6 weeks before NSRP)
  • Able to provide informed consent

Exclusion Criteria:

  • Adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater)
  • 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 (stages T3 or greater)
  • History of hypersensitivity to AMPYRA or 4-aminopyridine
  • Preoperative history of urinary incontinence and/or use of urinary incontinence pads
  • Patients with history of penile surgery
  • Renal impairment based on calculated GFR (GFR<80 mL/min)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701581


Contacts
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Contact: Elizabeth Galgocy (717) 531-8521 egalgocy@pennstatehealth.psu.edu
Contact: Ananya Das 7175314686 adas1@pennstatehealth.psu.edu

Locations
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United States, New York
University of Rochester Department of Urology Not yet recruiting
Rochester, New York, United States, 14642
Contact: Ahmed Ghazi    585-275-0126    ahmed_ghazi@urmc.rochester.edu   
Principal Investigator: John Elfar, MD         
Sub-Investigator: Ahmed Ghazi, MD         
Sub-Investigator: Edward Messing, MD         
Sub-Investigator: Mark Noble, MD         
Sponsors and Collaborators
University of Rochester
Milton S. Hershey Medical Center

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Responsible Party: John Elfar, Adjunct Associate Professor, Department of Orthopaedics (URMC) and Vice Chairman, Department of Orthopaedics and Rehabilitation (Penn State), University of Rochester
ClinicalTrials.gov Identifier: NCT03701581     History of Changes
Other Study ID Numbers: 57379
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action