70 Participants Needed

4-Aminopyridine for Nerve Injury

Recruiting at 2 trial locations
AD
EG
AH
Overseen ByAndrea Horne
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use any other aminopyridine medications.

Is 4-Aminopyridine generally safe for humans?

4-Aminopyridine is used in humans for conditions like multiple sclerosis and has been shown to improve nerve function. However, it can cause side effects such as tremors, excitability, and convulsions due to its effects on the central nervous system.12345

How does the drug 4-Aminopyridine differ from other treatments for nerve injury?

4-Aminopyridine (4-AP) is unique because it can be used both as a treatment and a diagnostic tool for nerve injuries, helping to differentiate between types of nerve damage. Unlike other treatments, 4-AP enhances nerve function by improving myelination (the protective covering of nerves) and nerve conduction, and it can be administered orally, transdermally (through the skin), or by injection.13456

What evidence supports the effectiveness of the drug 4-Aminopyridine for nerve injury?

Research shows that 4-Aminopyridine can improve nerve function and recovery after nerve injuries in mice by enhancing myelination (the protective covering of nerves), increasing muscle strength, and reducing nerve damage. It has also been used to help with symptoms in multiple sclerosis, suggesting its potential in improving nerve-related conditions.12345

Who Is on the Research Team?

JE

John Elfar, MD

Principal Investigator

University of Arizona

BL

Benjamin Lee, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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.

Inclusion 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 willing and able to give my consent to participate.
I am a man with early-stage prostate cancer planning to have a specific prostate surgery.
See 4 more

Exclusion Criteria

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.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 4-aminopyridine or placebo daily for 2 months post-surgery

8 weeks
Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Weekly assessments

Long-term follow-up

Participants continue to be monitored for long-term outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • 4-Aminopyridine
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: Investigational TreatmentExperimental Treatment1 Intervention
Group II: Group B: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

John Elfar

Lead Sponsor

Trials
4
Recruited
500+

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

University of Arizona

Collaborator

Trials
545
Recruited
161,000+

Milton S. Hershey Medical Center

Collaborator

Trials
515
Recruited
2,873,000+

Published Research Related to This Trial

4-Aminopyridine (4-AP) significantly improves motor function and enhances recovery after traumatic peripheral nerve injuries in mice, regardless of whether it is administered orally or through injection.
Chronic daily treatment with 4-AP leads to better myelination, increased muscle mass, and improved muscle force, indicating its potential as an effective therapy for nerve injuries.
Human equivalent dose of oral 4-aminopyridine differentiates nerve crush injury from transection injury and improves post-injury function in mice.Hsu, CG., Talukder, MAH., Yue, L., et al.[2020]
Transdermal administration of 4-aminopyridine (TD-4-AP) significantly enhances functional recovery and nerve conduction after traumatic peripheral nerve injury in mice, showing promise as a treatment method.
Chronic treatment with TD-4-AP leads to fewer degenerating axons and thicker myelin sheaths compared to controls, indicating its potential to promote nerve repair and improve motor function.
Transdermal delivery of 4-aminopyridine accelerates motor functional recovery and improves nerve morphology following sciatic nerve crush injury in mice.Clark, AR., Hsu, CG., Talukder, MAH., et al.[2021]
In a study involving 20 subjects (10 in the 4-AP-treated group and 10 in the control group), 4-aminopyridine (4-AP) significantly reduced clinical scores of experimental autoimmune neuritis (EAN), indicating its potential effectiveness in treating this condition.
The 4-AP-treated group also showed improved motor conductance velocity without causing any pathological changes, suggesting that it may be a safe therapeutic option for demyelinating neuropathy.
4-Aminopyridine ameliorates experimental autoimmune neuritis in Lewis rats.Moriguchi, K., Miyamoto, K., Kusunoki, S.[2018]

Citations

Human equivalent dose of oral 4-aminopyridine differentiates nerve crush injury from transection injury and improves post-injury function in mice. [2020]
Transdermal delivery of 4-aminopyridine accelerates motor functional recovery and improves nerve morphology following sciatic nerve crush injury in mice. [2021]
4-Aminopyridine ameliorates experimental autoimmune neuritis in Lewis rats. [2018]
4-Aminopyridine: A Single-Dose Diagnostic Agent to Differentiate Axonal Continuity in Nerve Injuries. [2022]
4-aminopyridine-a review. [2019]
The effects of 4-aminopyridine and methylprednisolone on recovery of the facial nerve crush injury. [2021]
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