Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Wounds and Injuries

Prostatic Neoplasms

Erectile Dysfunction

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Channel Blockers

All Drugs and Chemicals

4-Aminopyridine

Potassium Channel Blockers

* 4-Aminopyridine (FDA-approved drug)
* 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).

Subjects will receive an oral dose of placebo treatment the day after surgery, continuing daily for 3 months (90 days) following the same administration instructions as the investigational treatment. The placebo tablets will be manufactured by The University of Iowa Pharmaceuticals, 115 South Grand Avenue G-20, Iowa City, IA 52242. The Investigational Drug Service at the University of Rochester will manage the placebos.

Placebo composition will include:

97% Microcrystalline Cellulose, NF (Avicel Ph 102) 2% Sodium Starch Glycolate, NF

1% Magnesium Stearate, NF

The placebo will be covered in White Opadry, formulation OY-S-9603 and tooled to look similar to the investigational treatment.

Placebo will be tooled to look similar to the study drug.

Placebo

Thomas Osinski, MD

John Elfar, MD

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.

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.

Randomized placebo-controlled trial of 4AP vs placebo for nerve injury

Restricted to male subjects due to the inclusion criteria of prostate cancer.

4-aminopyridine Treatment for Nerve Injury

4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy

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.

Incontinence measurement (change over time)

Erectile function measurement tool. (change over time)

Specific questions regarding patient blinding

Subjects will record the time each day that they take the study drug/ placebo.

University of Arizona

John Elfar

Tenured Professor, Chairman, Department of Orthopaedic Surgery

Gland and Hormone Related Diseases

Mouth and Tooth Diseases

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Head and Neck Neoplasms

Parotid Neoplasms

Endocrine Gland Neoplasms

Endocrine System Diseases

Salivary Gland Neoplasms

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Parotid Diseases

Salivary Gland Diseases

Oral Cancer

Pharmaceutical Solutions

This arm of the study will include Dose Escalation/De-Escalation cohorts of ALM-488.

This arm of the study will include Dose Timing cohorts of ALM-488.

ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

ALM-488

Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head \& neck surgery.

This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an intravenous (IV) infusion to patients undergoing head \& neck surgery. The study will also characterize the pharmacokinetics of ALM-488 in this subject population and determine the dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence characteristics.

This is a Phase 1/Phase 2 study in patients undergoing Head \& Neck Surgery.

A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery

Incidence of ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Concentration of ALM-488 in blood at varying times following ALM-488 administration.

To determine the recommended dose of ALM-488.

To evaluate the effect of timing of administration of ALM-488.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
4-aminopyridine Treatment for Nerve Injury	NCT03701581	Nerve Injury Prostate Cancer	4-Aminopyridine Placebo	45 Years - 75 Years	University of Rochester
4-aminopyridine Treatment for Nerve Injury	NCT03701581	Nerve Injury Prostate Cancer	4-Aminopyridine Placebo	45 Years - 75 Years	University of Rochester
4-aminopyridine Treatment for Nerve Injury	NCT03701581	Nerve Injury Prostate Cancer	4-Aminopyridine Placebo	45 Years - 75 Years	University of Rochester
A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery	NCT04420689	Parotid Neoplas... Thyroid Neoplas... Head and Neck N... Surgery Nerve Injury Imaging	ALM-488	18 Years -	Alume Biosciences, Inc.
A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery	NCT04420689	Parotid Neoplas... Thyroid Neoplas... Head and Neck N... Surgery Nerve Injury Imaging	ALM-488	18 Years -	Alume Biosciences, Inc.

Spots Global Cancer Trial Database for nerve injury

Every month we try and update this database with for nerve injury cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.