4-aminopyridine Treatment for Nerve Injury
About this study
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
- Nerve Injury, Prostate Cancer
- Tested
- 4-Aminopyridine, Placebo
- Sponsor
- John Elfar
Who can join
- Age
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 11
- Minimum age: 45 years
- Maximum age: 75 years
- Eligible sex: Male
- Study condition: Nerve Injury, Prostate Cancer
- 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 9
- 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
Where
2 sites, 1 recruiting
University of Arizona
Tucson, Arizona, United States
University of Rochester
Rochester, New York, United States
Contact
-
Andrea Horne
520-626-6456 ahh@arizona.edu
Potential match only. Final eligibility is determined by the study team.