Safety and Tolerability of TAR-302-5018 in Subjects With Neurogenic Detrusor Overactivity Resulting From Spinal Cord Injury
- Conditions
- Neurogenic Detrusor Overactivity
- Interventions
- Drug: Trospium-Releasing Intravesical System (TAR-302-5018)
- Registration Number
- NCT03168828
- Lead Sponsor
- Taris Biomedical LLC
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAR-302-5018 Trospium-Releasing Intravesical System (TAR-302-5018) 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.
- Primary Outcome Measures
Name Time Method Safety of TAR-302-5018: Safety will be assessed throughout the study based on reported AEs 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. Safety will be assessed throughout the study based on reported AEs, investigational product events (IPEs), physical examinations (PEs), vital signs, clinical laboratory tests, scheduled cystoscopic examinations, bladder ultrasounds, bladder post-void residual volume (PVR), and the use of concomitant medications.
- Secondary Outcome Measures
Name Time Method Tolerability of TAR-302-5018 Tolerability will be assessed during the 42-day indwelling period unless removed due to lack of tolerability in advance of the Day 42 scheduled removal. Tolerability will be determined by the proportion of subjects who require TAR-302-5018 removal prior to the planned removal on Day 42 due to meeting any of the Subject Stopping Safety Criteria or other drug or device constituent related adverse event.
Peak Plasma Concentration (Cmax) Seven time-points across 49 days (Day 0 through Day 49). Plasma will be evaluated for trospium levels on Study Days 0, 3, 7, 14, 28, 42, and 49.
Peak Urine Concentration (Cmax) Seven time-points across 49 days (Day 0 through Day 49). Urine will be evaluated for trospium levels on Study Days 0, 3, 7, 14, 28, 42, and 49.
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume Day 0, Day 14 (+/- 1 day), Day 42 Instillation volume at maximum capacity (mL)
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Vesical Pressure Day 0, Day 14 (+/- 1 day), Day 42 Vesical pressure at maximal desire to urinate (cmH2O)
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Detrusor Pressure Day 0, Day 14 (+/- 1 day), Day 42 Detrusor pressure at maximum capacity (cmH2O)
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Bladder Compliance Day 0, Day 14 (+/- 1 day), Day 42 Bladder compliance (mL/cmH2O)
Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Instillation Volume Day 0, Day 14 (+/- 1 day), Day 42 Instillation Volume (mL)
Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Vesical Pressure Day 0, Day 14 (+/- 1 day), Day 42 Vesical pressure (cmH2O)
Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Peak Flow Day 0, Day 14 (+/- 1 day), Day 42 Peak flow (mL/s)
Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Mean Flow Day 0, Day 14 (+/- 1 day), Day 42 Mean flow (mL/s)
Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Detrusor Pressure Day 0, Day 14 (+/- 1 day), Day 42 Detrusor pressure at the peak flow (cmH2O)
Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Post Void Residual Volume Day 0, Day 14 (+/- 1 day), Day 42 Post void residual volume (mL)
Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Detrusor Pressure Day 0, Day 14 (+/- 1 day), Day 42 Detrusor pressure (cmH2O)
Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Total Voided Volume Day 0, Day 14 (+/- 1 day), Day 42 Total voided volume (mL)
Trial Locations
- 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