Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
70 participants
INTERVENTIONAL
2021-06-05
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A: Investigational Treatment
* FDA-approved 10mg dalfampridine (generic Ampyra)
* 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).
4-Aminopyridine
FDA-approved tablets.
Group B: Placebo
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.
Placebo
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Interventions
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4-Aminopyridine
FDA-approved tablets.
Placebo
Placebo will be tooled to look similar to the study drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
75 Years
MALE
No
Sponsors
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John Elfar
OTHER
Responsible Party
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John Elfar
Tenured Professor, Chairman, Department of Orthopaedic Surgery
Principal Investigators
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Rashid Sayyid, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
John Elfar, MD
Role: STUDY_CHAIR
University of Arizona
Locations
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University of Arizona
Tucson, Arizona, United States
University of Rochester
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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00003869
Identifier Type: -
Identifier Source: org_study_id