Safety and Efficacy Study OnabotulinumtoxinA for the Treatment of Urinary Incontinence in Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01600716
First received: May 15, 2012
Last updated: March 11, 2014
Last verified: March 2014

May 15, 2012
March 11, 2014
June 2012
May 2014   (final data collection date for primary outcome measure)
Number of Urinary Incontinence Episodes [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01600716 on ClinicalTrials.gov Archive Site
  • Maximum Cystometric Capacity (MCC) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Incontinence Quality of Life Instrument (I-QOL) Total Summary Score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study OnabotulinumtoxinA for the Treatment of Urinary Incontinence in Multiple Sclerosis
Not Provided

This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) in urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Urinary Incontinence
  • Multiple Sclerosis
  • Biological: OnabotulinumtoxinA
    OnabotulinumtoxinA 100 U will be administered into the detrusor at Day 1, followed by a second treatment, if applicable, administered at the earliest 12 weeks after the first treatment. OR, if treated with Placebo on Day 1, onabotulinumtoxinA 100 U will be administered, if applicable, at the earliest 12 weeks after treatment with placebo (normal saline).
    Other Names:
    • BOTOX®
    • botulinum toxin Type A
  • Drug: Placebo (Normal Saline)
    Placebo (normal saline) will be administered into the detrusor at Day 1.
  • Experimental: OnabotulinumtoxinA
    OnabotulinumtoxinA 100 U will be administered into the detrusor at Day 1. A second treatment, if applicable, will be administered at the earliest 12 weeks after the first treatment.
    Intervention: Biological: OnabotulinumtoxinA
  • Placebo (Normal Saline)
    Placebo (normal saline) will be administered into the detrusor at Day 1. If applicable, onabotulinumtoxinA 100 U will be administered at the earliest 12 weeks after treatment with placebo (normal saline).
    Interventions:
    • Biological: OnabotulinumtoxinA
    • Drug: Placebo (Normal Saline)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
185
April 2015
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 3 episodes of urinary incontinence over a 3-day period
  • History of Multiple Sclerosis (MS)
  • Urinary incontinence not adequately controlled by anticholinergic medication

Exclusion Criteria:

  • Current use of intermittent catheter or indwelling catheter to manage urinary incontinence
  • Previous or current botulinum toxin therapy of any serotype for any urological condition
  • Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks
  • Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Czech Republic,   France,   Poland,   Portugal,   Russian Federation
 
NCT01600716
191622-117
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP