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

NCT03168828 | Completed Phase 1 FDA Drug

• 1 other identifier: TAR-302-101
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

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).

Conditions

Neurogenic Detrusor Overactivity

Outcome Measures

Primary Outcomes (1)

• Safety of TAR-302-5018: Safety will be assessed throughout the study based on reported AEs

  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.

  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.

Secondary Outcomes (20)

• 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.

• Peak Plasma Concentration (Cmax)

  Seven time-points across 49 days (Day 0 through Day 49).

• Peak Urine Concentration (Cmax)

  Seven time-points across 49 days (Day 0 through Day 49).

• Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume

  Day 0, Day 14 (+/- 1 day), Day 42

• Preliminary Urodynamic Efficacy: Vesical Filling Phase - Vesical Pressure

  Day 0, Day 14 (+/- 1 day), Day 42

Other Outcomes (1)

• The Change in Quality of Life as assessed by Qualiveen Surveys

  Three time-points across 42 days (Study Day 0 to Study Day 42).

Study Arms (1)

TAR-302-5018

EXPERIMENTAL

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.

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

Interventions

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

TAR-302-5018 is a passive, nonresorbable trospium-releasing intravesical system whose primary mode of action is the controlled release of trospium into the bladder over a 42-day period.

TAR-302-5018

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of traumatic or nontraumatic suprasacral SCI for longer than 6 months and a documented history of NDO.
• Age ≥ 18 years.
• 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
• History of non-stress-based urinary incontinence.

You may not qualify if:

• Participation in another drug or device study within 60 days prior to the screening visit.
• Previous urologic surgery that either decreases outlet resistance (transurethral prostatectomy, urethral stent, sphincterotomy) or changes native bladder anatomy (bladder augmentation).
• Presence of significant renal dysfunction at screening (Glomerular Filtration Rate \< 30 mL/min).
• Presence of significant polyuria of any cause at screening (urine output \> 4,000 mL/day).
• History of pelvic radiation.
• Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
• Symptomatic autonomic dysreflexia requiring ongoing treatment.
• In the opinion of the investigator, the subject has a history of significant stress urinary incontinence.
• Subjects with active bladder stones or history of bladder stones \< 6 months prior to study entry.
• History of recurrent symptomatic UTIs (\> 6 per 1 year).
• Subjects with either untreated urinary retention or gastric retention or uncontrolled narrow-angle glaucoma.
• Subjects with known hypersensitivity to trospium or chemically-related drugs.
• Subjects with known hypersensitivity to nitinol or silicone.
• Subjects actively taking oral trospium. If previously used and discontinued, these medications must have been stopped for \>2 weeks.
• The addition of a new or a change in dose to a current medication for the treatment of OAB (i.e. anticholinergics, beta-3 adrenergic agonists, antispasmodics, antidepressants, or hormones) within 30 days prior to signing the Informed Consent Form (ICF). A current dose must continue through the final study visit. If previously used and discontinued, these medications must have been stopped for \> 2 weeks prior to Day 0.

Sponsors & Collaborators

• Taris Biomedical LLC: lead

Study Sites (4)

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

Carolinas HealthCare System

Charlotte, North Carolina, 28207, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

Virginia Mason

Seattle, Washington, 98101, United States

Location

Study Officials

• Michael Kennelly, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: May 30, 2017
• Study Start: April 24, 2017
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (4)