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

This study is currently recruiting participants.
Verified January 2013 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01600716
First received: May 15, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Urinary Incontinence
Multiple Sclerosis
 Biological: OnabotulinumtoxinA
Drug: Placebo (Normal Saline)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Urinary Incontinence Episodes [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 184
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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).
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600716

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
United States, Washington
Recruiting
Mountlake Terrace, Washington, United States
Belgium
Recruiting
Liege, Belgium
Canada, British Columbia
Recruiting
Victoria, British Columbia, Canada
Czech Republic
Recruiting
Olomouc, Czech Republic
France
Not yet recruiting
Garches, France
Recruiting
Marseille, France
Poland
Not yet recruiting
Wroclaw, Poland
Portugal
Not yet recruiting
Porto, Portugal
Russian Federation
Not yet recruiting
Moscow, Russian Federation
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
More information  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01600716     History of Changes
Other Study ID Numbers: 191622-117
Study First Received: May 15, 2012
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Urinary Incontinence
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Urination Disorders
Urologic Diseases
 Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013