NCT03701581 4-aminopyridine Treatment for Nerve Injury
| NCT ID | NCT03701581 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | John Elfar |
| Condition | Nerve Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-06-05 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2021-06-05 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria * 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 Criteria * 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
Contact & Investigator
Rashid Sayyid, MD
PRINCIPAL INVESTIGATOR
University of Arizona
Frequently Asked Questions
Who can join the NCT03701581 clinical trial?
This trial is open to male participants only, aged 45 Years or older, up to 75 Years, studying Nerve Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03701581 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03701581 currently recruiting?
Yes, NCT03701581 is actively recruiting participants. Contact the research team at ahh@arizona.edu for enrollment information.
Where is the NCT03701581 trial being conducted?
This trial is being conducted at Tucson, United States, Rochester, United States.
Who is sponsoring the NCT03701581 clinical trial?
NCT03701581 is sponsored by John Elfar. The principal investigator is Rashid Sayyid, MD at University of Arizona. The trial plans to enroll 70 participants.