Neurogenic Detrusor Overactivity Clinical Trial
Official title:
Prospective Randomized Double-blind Trial of Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity and Urinary Incontinence Related to Spinal Cord Injury or Multiple Sclerosis
This is a prospective, multicentre (7 sites), randomized, double-blind, study comparing
intravesical injection of BOTOX to placebo in 56 subjects with NDO secondary to spinal cord
injury or multiple sclerosis. Study subjects will be randomized to one of the following two
treatment groups:
Group 1 n=28 BOTOX - 300U Group 2 n=28 Placebo BOTOX (saline)
All study subjects will receive one injection cycle (BOTOX 300U or Placebo) at Visit 2
(Treatment, Day 0) as per Supplement III. The study duration is approximately 61 weeks and
consists of a Pre-Treatment Evaluation, a Treatment/Randomization Visit (Visit 2, Day 0),
Telephone Follow-ups at 1, 3 and 4 weeks post-treatment, and Follow-up Visits at 6, 24 and
36 weeks (Visits 3 to 5). At Week 36, subjects will be offered open-label BOTOX 300U and
will be followed for an additional 6 months, returning for evaluations at Weeks 48 and 60.
This is a prospective, multicentre (7 sites), randomized, double-blind, study comparing
intravesical injection of BOTOX to placebo in 56 subjects with NDO secondary to spinal cord
injury or multiple sclerosis. Study subjects will be randomized to one of the following two
treatment groups:
Group 1 n=28 BOTOX - 300U Group 2 n=28 Placebo BOTOX (saline) All study subjects will
receive one injection cycle (BOTOX 300U or Placebo) at Visit 2 (Treatment, Day 0) as per
Supplement III. The study duration is approximately 61 weeks and consists of a Pre-Treatment
Evaluation, a Treatment/Randomization Visit (Visit 2, Day 0), Telephone Follow-ups at 1, 3
and 4 weeks post-treatment, and Follow-up Visits at 6, 24 and 36 weeks (Visits 3 to 5). At
Week 36, subjects will be offered open-label BOTOX 300U and will be followed for an
additional 6 months, returning for evaluations at Weeks 48 and 60.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01981954 -
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)
|
Phase 3 | |
| Completed |
NCT02211846 -
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
|
Phase 1 | |
| Terminated |
NCT00712322 -
A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity
|
Phase 2 | |
| Recruiting |
NCT06059066 -
Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
|
N/A | |
| Recruiting |
NCT05491525 -
A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC
|
Phase 2/Phase 3 | |
| Completed |
NCT02138149 -
Is the Nerve Growth Factor (NGF) a Useful Biomarker in Neurogenic Bladder Dysfunction After Spinal Cord Injury?
|
N/A | |
| Completed |
NCT04478357 -
BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED-RELEASE TABLETS (TOVIAZ™), MANUFACTURED AT ZWICKAU VERSUS FREIBURG
|
Phase 1 | |
| Completed |
NCT00857896 -
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
|
Phase 2 | |
| Completed |
NCT00800462 -
Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
|
Phase 4 | |
| Completed |
NCT01539707 -
Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder
|
Phase 1 | |
| Completed |
NCT03482037 -
Effects of Rec 0/0438 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury
|
Phase 1/Phase 2 | |
| Completed |
NCT04452838 -
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
|
Phase 1 | |
| Completed |
NCT02751931 -
Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity
|
Phase 3 | |
| Active, not recruiting |
NCT05502614 -
Dorsal Genital Nerve Stimulation for Bladder Management After SCI
|
N/A | |
| Recruiting |
NCT05621616 -
A Study of Mirabegron in Young Children With Neurogenic Detrusor Overactivity
|
Phase 3 | |
| Withdrawn |
NCT01043848 -
Treatment of Neurogenic Detrusor Overactivity: Early Versus Late Pudendal Nerve Stimulation in Spinal Cord Injury (SCI) Patients
|
N/A | |
| Completed |
NCT02526979 -
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)
|
Phase 1 | |
| Completed |
NCT01565694 -
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
|
Phase 3 | |
| Completed |
NCT03168828 -
Safety and Tolerability of TAR-302-5018 in Subjects With Neurogenic Detrusor Overactivity Resulting From Spinal Cord Injury
|
Phase 1 |