4-aminopyridine Treatment for Nerve Injury

Part of paid clinical trials in Tucson, Arizona.

Sponsor
John Elfar
Study ID
NCT03701581
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 4-Aminopyridine — DRUG
    FDA-approved tablets.
  • Placebo — OTHER
    Placebo will be tooled to look similar to the study drug.

Study Details

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.

Key Dates

Start date
Jun 5, 2021
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Investigational Treatment
    * 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).
  • Placebo Comparator: Group B: Placebo
    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.

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). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724
John Elfar, MD
[email protected]
Carly J Deal
[email protected]
520-626-6456
Rashid Sayyid, MD (PRINCIPAL_INVESTIGATOR)
Juan Chipollini, MD (SUB_INVESTIGATOR)
John Elfar, MD (SUB_INVESTIGATOR)
Benjamin Lee, MD (SUB_INVESTIGATOR)
University of RochesterRochesterNew York14602-

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