Nerve InjuryPhase 2/3NCT03701581
4-aminopyridine Treatment for Nerve Injury
A Phase 2/3 study testing 4-Aminopyridine in people with Nerve Injury and Prostate Cancer, run by John Elfar at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Nerve Injury, Prostate Cancer
- What is being tested?
- 4-Aminopyridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2021to Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Terminated
University of Rochester
Rochester, New York, 14602
- Recruiting
University of Arizona
Tucson, Arizona, 85724
John Elfar, MD, elfar@arizona.edu
Carly J Deal, 520-626-6456, carlyjdeal@arizona.edu
About this study
Official title: 4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy
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.
Read the detailed description
To evaluate the role of 4-AP on the recovery of nerve function we will be giving patients with prostate cancer who are undergoing robot assisted radical prostatectomy (RP) either 4-AP or placebo in the perioperative period. This population of patients was selected as nerve crush injury during RP is thought to contribute to erectile dysfunction and urinary continence post operatively.
- Conditions
- Nerve Injury, Prostate Cancer
- Being tested
- 4-Aminopyridine, Placebo
- Keywords
- prostatectomy, erectile dysfunction, prostate cancer, nerve injury, incontinence
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-AminopyridineDrug
Also called 4-AP, Fampridine, Dalfampridine
FDA-approved tablets.
PlaceboOther
Placebo will be tooled to look similar to the study drug.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Investigational Treatment | Experimental | * 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). Receives: Drug: 4-Aminopyridine |
| Group B: Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan Incontinence Sympton Index (M-ISI) (change over time)
Incontinence measurement (change over time)
Measured: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
International Index of Erectile Function (IIEF) (change over time)
Erectile function measurement tool. (change over time)
Measured: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
Placebo vs. Active Drug Questionnaire
Specific questions regarding patient blinding
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Drug Diary
Subjects will record the time each day that they take the study drug/ placebo.
Measured: Daily for 90 days.
Attempted Sexual Activity Questionnaire
Sexual activity assessment
Measured: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start5 Jun 2021
- Primary completionJul 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled trial of 4AP vs placebo for nerve injury
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Elfar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Elfar, University of Arizona
- Investigators
- Rashid Sayyid, MD, Principal investigator, University of ArizonaJohn Elfar, MD, Study chair, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701581
- Sponsor's protocol ID
- 00003869
- Status last verified
- Dec 2025
- First submitted
- 25 Oct 2017
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of the study, de-identified patient outcomes will be provided with publication of results. This includes outcomes data as listed in the primary and secondary outcomes sections.
Publications
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.
PubMed 38773595
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy
- ClinicalTrials.gov ID
- NCT03701581
- Acronym / sponsor ID
- 00003869
- Conditions
- Nerve Injury, Prostate Cancer
- Keywords
- prostatectomy, erectile dysfunction, prostate cancer, nerve injury, incontinence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- John ElfarUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To evaluate the role of 4-AP on the recovery of nerve function we will be giving patients with prostate cancer who are undergoing robot assisted radical prostatectomy (RP) either 4-AP or placebo in the perioperative period. This population of patients was selected as nerve crush injury during RP is thought to contribute to erectile dysfunction and urinary continence post operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled trial of 4AP vs placebo for nerve injury
| Arm | Type | Receives |
|---|---|---|
| Group A: Investigational Treatment | Experimental | Drug: 4-Aminopyridine* 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). |
| Group B: Placebo | Placebo comparator | Other: PlaceboSubjects 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-AminopyridineAlso: 4-AP, Fampridine, DalfampridineFDA-approved tablets. | Drug | Group A: Investigational Treatment |
| PlaceboPlacebo will be tooled to look similar to the study drug. | Other | Group B: Placebo |
Primary outcome
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)
Placebo vs. Active Drug Questionnaire
Time frame: through study completion, an average of 1 year
Specific questions regarding patient blinding
2 secondary outcomes
Drug Diary
Time frame: Daily for 90 days.
Attempted Sexual Activity Questionnaire
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 38773595Ghazi 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.
- Individual participant dataSharing planned: Yes. At the conclusion of the study, de-identified patient outcomes will be provided with publication of results. This includes outcomes data as listed in the primary and secondary outcomes sections.
Related trials for Nerve Injury
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rashid Sayyid, MD principal investigator
University of Arizona
John Elfar, MD study chair
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 4-Aminopyridine in people with Nerve Injury and Prostate Cancer, run by John Elfar at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Horne (520-626-6456, ahh@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.