NCT03658408

Brief Summary

The purpose of this study is to see if the study drug 4-aminopyridine (4-AP) can help speed up the recovery of peripheral nerve injury after prostatectomy. 4-AP is a potassium channel blocker used to improve walking in multiple sclerosis patients. Investigators will measure the effect that 4-AP may have on the recovery of sexual function and urinary incontinence after prostatectomy.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

October 3, 2018

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

27 days

First QC Date

August 31, 2018

Last Update Submit

October 31, 2018

Conditions

Prostate Disease

Outcome Measures

Primary Outcomes (1)

  • percentage of participants with normal erectile dysfunction

    Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.

    2 months

Secondary Outcomes (14)

  • the time point at which the highest number of subjects reporting normal erectile dysfunction

    baseline to month 12

  • percentage of participants with normal erectile dysfunction

    week 3

  • percentage of participants with normal erectile dysfunction

    week 4

  • percentage of participants with normal erectile dysfunction

    week 6

  • percentage of participants with normal erectile dysfunction

    week 8

  • +9 more secondary outcomes

Study Arms (2)

4-aminopyridine

EXPERIMENTAL

Participants with recent prostatectomies receiving 4-aminopyridine

Drug: 4-aminopyridine

Placebo

PLACEBO COMPARATOR

Participants with recent prostatectomies receiving placebo

Drug: placebo

Interventions

4-aminopyridineDRUG

Oral tablet of 2.5 mg given 4 times a day

4-aminopyridine
placeboDRUG

2.5 mg sugar pill given orally 4 times a day

Placebo

Eligibility Criteria

Age45 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must have prostate disease (only males)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 10 ng/ml, 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 International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening
  • Is sexually active for at least 6 months with sexual activity within 6 weeks preceding prostate biopsy or surgery.
  • Willingness to participate and able to provide informed consent

You may not qualify if:

  • 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.
  • History of prior phosphodiesterase inhibitor use
  • 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 AMPYRA® or 4-aminopyridine
  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Prostatic Diseases

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 5, 2018

Study Start

October 3, 2018

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

November 2, 2018

Record last verified: 2018-10

Locations

US(1)