4-aminopyridine Treatment for Nerve Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03701581|
Recruitment Status : Not yet recruiting
First Posted : October 10, 2018
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 4-Aminopyridine Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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 :||June 1, 2020|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||December 1, 2022|
Experimental: Group A: Investigational Treatment
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.
Placebo will be tooled to look similar to the study drug.
- 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)
- 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)
- Drug Diary [ Time Frame: Daily for 90 days. ]Subjects will record the time each day that they take the study drug/ placebo.
- 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)
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
|Contact: Elizabeth Galgocy||(717) firstname.lastname@example.org|
|Contact: Ananya Dasemail@example.com|
|United States, New York|
|University of Rochester Department of Urology|
|Rochester, New York, United States, 14642|
|Contact: Ahmed Ghazi 585-275-0126 firstname.lastname@example.org|
|Principal Investigator: John Elfar, MD|
|Sub-Investigator: Ahmed Ghazi, MD|
|Sub-Investigator: Edward Messing, MD|
|Sub-Investigator: Mark Noble, MD|