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COMPLETEDPHASE1

Safety and Tolerability of TAR-302-5018 in Subjects With Neurogenic Detrusor Overactivity Resulting From Spinal Cord Injury

A Prospective, Multi-center, Open-label Study of Trospium Delivered Intravesically by TAR-302-5018 to Spinal Cord Injury Subjects With Neurogenic Detrusor Overactivity (NDO)

NCT03168828•Taris Biomedical LLC

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of traumatic or nontraumatic suprasacral SCI for longer than 6 months and a documented history of NDO.
•2. Age ≥ 18 years.
•3. Demonstrated competence in and currently uses intermittent catheterization (IC) to empty the bladder (minimum of 4 IC events/day).
•* No indwelling catheter permitted
•* Caregiver may perform IC
•* Subject must be willing to maintain an established IC frequency throughout the study
•4. History of non-stress-based urinary incontinence.

Exclusion Criteria

•1. Participation in another drug or device study within 60 days prior to the screening visit.
•2. Previous urologic surgery that either decreases outlet resistance (transurethral prostatectomy, urethral stent, sphincterotomy) or changes native bladder anatomy (bladder augmentation).
•3. Presence of significant renal dysfunction at screening (Glomerular Filtration Rate \< 30 mL/min).
•4. Presence of significant polyuria of any cause at screening (urine output \> 4,000 mL/day).
•5. History of pelvic radiation.
•6. History of either bladder cancer or bladder pathology that the investigator deems unfit for study inclusion.
•7. Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
•8. Symptomatic autonomic dysreflexia requiring ongoing treatment.
•9. In the opinion of the investigator, the subject has a history of significant stress urinary incontinence.
•10. Subjects with active bladder stones or history of bladder stones \< 6 months prior to study entry.
+21 more criteria

Locations (4)

Michigan Institute of Urology

Troy, Michigan, United States

Carolinas HealthCare System

Charlotte, North Carolina, United States

Urology of Virginia

Virginia Beach, Virginia, United States

Virginia Mason

Seattle, Washington, United States

Key Dates

Start Date

April 24, 2017

Primary Completion Date

July 26, 2018

Completion Date

July 26, 2018

Last Updated

January 13, 2020

Enrollment

ACTUAL participants

Conditions

Neurogenic Detrusor Overactivity

Interventions

Trospium-Releasing Intravesical System (TAR-302-5018)

DRUG

A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

NCT01565694

Neurogenic Detrusor Overactivity

View study

COMPLETEDPHASE3

A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

NCT01981954

Neurogenic Detrusor OveractivityPediatric

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability of TAR-302-5018 in Subjects With Neurogenic Detrusor Overactivity Resulting From Spinal Cord Injury

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

Study To Assess The Bioequivalence Under Fed And Fasted Conditions Of The Fesoterodine Beads-In-Capsule SR4 And SR7 Formulations And To Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The Beads-In-Capsule SR7 Formulation Administer