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A Long-Term Extension Study of OnabotulinumtoxinA for Urinary Incontinence Due to Neurogenic Detrusor Overactivity

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ClinicalTrials.gov Identifier: NCT01852058
Recruitment Status : Recruiting
First Posted : May 13, 2013
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA for the treatment of urinary incontinence due to neurogenic detrusor overactivity in patients who successfully completed Study 191622-120.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Biological: OnabotulinumtoxinA Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Extension Study of BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
Actual Study Start Date : January 6, 2014
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OnabotulinumtoxinA Dose A
OnabotulinumtoxinA Dose A injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.
Other Names:
  • BOTOX®
  • botulinum toxin A

Experimental: OnabotulinumtoxinA Dose B
OnabotulinumtoxinA Dose B injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.
Other Names:
  • BOTOX®
  • botulinum toxin A

Experimental: OnabotulinumtoxinA Dose C
OnabotulinumtoxinA Dose C injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.
Other Names:
  • BOTOX®
  • botulinum toxin A




Primary Outcome Measures :
  1. Change from Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes [ Time Frame: Baseline, 60 Weeks ]

Secondary Outcome Measures :
  1. Change from Baseline in Average Urine Volume at First Morning Catheterization [ Time Frame: Baseline, 60 Weeks ]
  2. Percentage of Patients With Night Time Urinary Incontinence [ Time Frame: 60 Weeks ]
  3. Time to Patient Request for Retreatment [ Time Frame: 48 Weeks ]
  4. Time to Patient Qualification for Retreatment [ Time Frame: 48 Weeks ]


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Ages Eligible for Study:   5 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Successfully completed participation in Study 191622-120
  • Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120
  • Regularly using clean intermittent catheterization to empty the bladder

Exclusion Criteria:

  • Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
  • Current or planned use of a baclofen pump
  • Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
  • Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder
  • Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype for any other condition since entering study 191622-120

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852058


Contacts
Contact: Clinical Trials Registry Team 1-800-347-4500 IR-CTRegistration@allergan.com

  Show 43 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Katy Eravci Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01852058     History of Changes
Other Study ID Numbers: 191622-121
2012-004898-30 ( EudraCT Number )
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents