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Potassium Channel Blocker
4-Aminopyridine for Nerve Injury
Phase 2 & 3
Waitlist Available
Led By Thomas Osinski, MD
Research Sponsored by John Elfar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing whether 4-aminopyridine can speed up the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.
Who is the study for?
Men aged 45-75 with early-stage, non-metastatic prostate cancer scheduled for nerve-sparing prostate surgery. They must have a PSA level under 15 ng/ml, no history of recurrent or advanced prostate cancer, and not need postoperative therapy. Participants should be sexually active with an erectile function score of at least 17 and cannot use other treatments for erectile dysfunction until three months after surgery.Check my eligibility
What is being tested?
The trial is testing if the drug 4-aminopyridine can speed up recovery from nerve damage caused by traction or crush injuries during prostate surgery. Patients will either receive the actual drug or a placebo to compare outcomes.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with similar medications include skin irritation, dizziness, nausea, and potential allergic reactions. People sensitive to this type of medication or those with kidney issues are excluded.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man with early-stage prostate cancer planning to have a specific prostate surgery.
Select...
My PSA level is under 15, and I won't need further treatment after surgery.
Select...
I am between 45 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
International Index of Erectile Function (IIEF) (change over time)
Michigan Incontinence Sympton Index (M-ISI) (change over time)
University of Rochester Placebo vs. Active Drug Questionnaire
Secondary outcome measures
Drug Diary
University of Rochester Attempted Sexual Activity Questionnaire
Side effects data
From 2013 Phase 4 trial • 901 Patients • NCT0148007612%
Insomnia
10%
Headache
9%
Multiple Sclerosis Relapse
8%
Urinary Tract Infection
8%
Nasopharyngitis
8%
Nausea
7%
Fall
5%
Dizziness
4%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Responder
All Participants
Non-responder
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: Investigational TreatmentExperimental Treatment1 Intervention
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).
Group II: Group B: PlaceboPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of ArizonaOTHER
514 Previous Clinical Trials
148,201 Total Patients Enrolled
John ElfarLead Sponsor
2 Previous Clinical Trials
228 Total Patients Enrolled
Milton S. Hershey Medical CenterOTHER
492 Previous Clinical Trials
2,798,752 Total Patients Enrolled
1 Trials studying Nerve Injury
1 Patients Enrolled for Nerve Injury
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been sexually active regularly for the last 6 months and in the 12 weeks before my prostate biopsy or surgery.I am scheduled for additional treatment after surgery for prostate cancer due to its advanced stage or spread.My prostate cancer has spread beyond the prostate.I am not taking any aminopyridine medications for any condition.I am willing and able to give my consent to participate.I have received treatment before my prostate surgery.My prostate cancer has come back after treatment.I have a history of seizures, multiple sclerosis, stroke, or another neurological disorder.I am a man with early-stage prostate cancer planning to have a specific prostate surgery.My PSA level is under 15, and I won't need further treatment after surgery.I agree not to use erectile dysfunction treatments for 3 months after surgery.My kidney function is reduced.I have had penile surgery, but only for circumcision or urethral issues.I am between 45 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: Investigational Treatment
- Group 2: Group B: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would this experimental procedure be appropriate for an adult over the age of 40?
"The age range that is eligible to participate in this trial is between 45 and 75 years old."
Answered by AI
What is the efficacy of 4-Aminopyridine?
"Currently, 5 clinical trials for 4-Aminopyridine are ongoing with 2 in Phase 3. Although a majority of these research studies are based in London, Ontario, there are 9 total locations running these trials."
Answered by AI
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