← Back to Search

Drug Delivery System

TAR-302-5018 for Neurogenic Detrusor Overactivity

Phase 1
Waitlist Available
Led By Michael Kennelly, MD
Research Sponsored by Taris Biomedical LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up safety will be assessed from the signing of the informed consent form through study day 49 (+ 7 days) for a total of up to 77 days.
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI).

Eligible Conditions
  • Neurogenic Detrusor Overactivity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~safety will be assessed from the signing of the informed consent form through study day 49 (+ 7 days) for a total of up to 77 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and safety will be assessed from the signing of the informed consent form through study day 49 (+ 7 days) for a total of up to 77 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of TAR-302-5018: Safety will be assessed throughout the study based on reported AEs
Secondary study objectives
Peak Plasma Concentration (Cmax)
Peak Urine Concentration (Cmax)
Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Detrusor Pressure
+12 more
Other study objectives
The Change in Quality of Life as assessed by Qualiveen Surveys

Side effects data

From 2009 Phase 4 trial • 12 Patients • NCT00863551
58%
Headache
25%
Vomiting
25%
Nausea
17%
Constipation
17%
Dry Mouth
17%
Flatulence
17%
Low back pain
8%
Folliculitis
8%
Change in taste
8%
Anxiety
8%
Increased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trospium Chloride Extended Release, 60 mg

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TAR-302-5018Experimental Treatment1 Intervention
Trospium-Releasing Intravesical System (TAR-302-5018) is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 42. TAR-302-5018 releases trospium gradually during the 42 day indwelling time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trospium
FDA approved

Find a Location

Who is running the clinical trial?

Taris Biomedical LLCLead Sponsor
4 Previous Clinical Trials
91 Total Patients Enrolled
Michael Kennelly, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
351 Total Patients Enrolled
~1 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top