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Neurogenic Detrusor OveractivityPhase 1NCT03168828

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

A Phase 1 study testing Trospium-Releasing Intravesical System (TAR-302-5018) in people with Neurogenic Detrusor Overactivity, run by Taris Biomedical LLC at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neurogenic Detrusor Overactivity
What is being tested?
Trospium-Releasing Intravesical System (TAR-302-5018)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
4 sitesUnited States
Study dates
24 Apr 2017to 26 Jul 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • History of either bladder cancer or bladder pathology that the investigator deems unfit for study inclusion.
Show all 31Show fewer
  • 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.
  • Intravesical onabotulinum toxin use within the last 9 months prior to the screening visit.
  • Intravesical anticholinergic medications within the last 30 days prior to the screening visit.
  • History of non-medication based therapy (i.e. Interstim therapy) for the treatment of OAB. History of non-invasive neuromodulation (i.e. Percutaneous Tibial Nerve Stimulation (PTNS)) is allowed if discontinued at least 8 weeks prior to Study Day 0.
  • Female subject who is pregnant (as verified by urine test at time of screening) or lactating or of childbearing potential and not using acceptable methods of contraception.
  • Subject has a medical condition that may cause noncompliance with the study protocol.
  • Subject refuses to provide written informed consent.
  • Subject will be unable or unwilling to complete the questionnaires, diaries, or attend all protocol mandated study visits.
  • Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use or removal of TAR-302-5018.
  • History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder that, in the opinion of the investigator, contraindicates participation.
  • History of any of the following within 3 months prior to Screening Visit:
  • Major illness/major surgery (requiring hospitalization), including pelvic, lower back surgery or procedure unrelated to bladder cancer; most outpatient procedures are not exclusionary
  • Renal or ureteral stone disease or instrumentation
  • Childbirth
  • Difficulty providing blood samples.
  • Other unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Carolinas HealthCare System

    Charlotte, North Carolina, 28207

  • Virginia Mason

    Seattle, Washington, 98101

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

Other trials in United States

About this study

Official title: 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)

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).

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03168828
Study groupRoleWhat they receive
TAR-302-5018ExperimentalTrospium-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.
Receives: Drug: Trospium-Releasing Intravesical System (TAR-302-5018)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Tolerability of TAR-302-5018

    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.

    Measured: 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.

  2. Peak Plasma Concentration (Cmax)

    Plasma will be evaluated for trospium levels on Study Days 0, 3, 7, 14, 28, 42, and 49.

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

  3. Peak Urine Concentration (Cmax)

    Urine will be evaluated for trospium levels on Study Days 0, 3, 7, 14, 28, 42, and 49.

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

  4. Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume

    Instillation volume at first sensation (mL)

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

  5. Preliminary Urodynamic Efficacy: Vesical Filling Phase - Vesical Pressure

    Vesical pressure at first sensation (cmH2O)

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

  6. Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume

    Instillation volume at first desire to urinate (mL)

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

  7. Preliminary Urodynamic Efficacy: Vesical Filling Phase - Vesical Pressure

    Vesical pressure at first desire to urinate (cmH2O)

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

  8. Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume

    Instillation volume at maximal desire to urinate (mL)

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

  9. Preliminary Urodynamic Efficacy: Vesical Filling Phase - Vesical Pressure

    Vesical pressure at maximal desire to urinate (cmH2O)

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

  10. Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume

    Instillation volume at maximum capacity (mL)

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

  11. Preliminary Urodynamic Efficacy: Vesical Filling Phase - Detrusor Pressure

    Detrusor pressure at maximum capacity (cmH2O)

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

  12. Preliminary Urodynamic Efficacy: Vesical Filling Phase - Bladder Compliance

    Bladder compliance (mL/cmH2O)

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

  13. Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Instillation Volume

    Instillation Volume (mL)

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

  14. Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Vesical Pressure

    Vesical pressure (cmH2O)

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

  15. Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Detrusor Pressure

    Detrusor pressure (cmH2O)

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

  16. Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Peak Flow

    Peak flow (mL/s)

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

  17. Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Mean Flow

    Mean flow (mL/s)

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

  18. Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Detrusor Pressure

    Detrusor pressure at the peak flow (cmH2O)

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

  19. Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Total Voided Volume

    Total voided volume (mL)

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

  20. Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Post Void Residual Volume

    Post void residual volume (mL)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start24 Apr 2017
  3. Primary completion26 Jul 2018
  4. Study completion26 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03168828
Sponsor's protocol ID
TAR-302-101
Status last verified
Jan 2020
First submitted
6 Apr 2017
Last updated
13 Jan 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Trospium-Releasing Intravesical System (TAR-302-5018) in people with Neurogenic Detrusor Overactivity, run by Taris Biomedical LLC at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of TAR-302-5018: Safety will be assessed throughout the study based on reported AEs (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03168828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

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