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

NCT01852058 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 191622-1212012-004898-30
• Study Type: interventional
• Target: 95
• Locations: 8 countries
• Sites: 30

Brief Summary

This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in participants who successfully completed Study 191622-120 (NCT01852045).

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (3)

• Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1

  Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.

  Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1

• Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2

  Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.

  Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2

• Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3

  Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.

  Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3

Secondary Outcomes (15)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)

  First injection on Day 1 in Study 120 through completion of Study 121 (Up to 108 weeks)

• Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 1

  Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1

• Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 2

  Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2

• Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 3

  Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3

• Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 1

  Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1

Study Arms (3)

OnabotulinumtoxinA 50 U

EXPERIMENTAL

Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).

Biological: OnabotulinumtoxinA

OnabotulinumtoxinA 100 U

EXPERIMENTAL

Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).

Biological: OnabotulinumtoxinA

OnabotulinumtoxinA 200 U

EXPERIMENTAL

Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).

Biological: OnabotulinumtoxinA

Interventions

OnabotulinumtoxinA BIOLOGICAL

OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.

Also known as: BOTOX®, botulinum toxin Type A

OnabotulinumtoxinA 100 U; OnabotulinumtoxinA 200 U; OnabotulinumtoxinA 50 U

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (30)

University of Alabama at Birmingham Division of Urology Research Office

Birmingham, Alabama, 35294, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46032, United States

Location

William Beaumont Hospital Research Institute

Royal Oak, Michigan, 48073, United States

Location

St. Louis Children's Hospital Division of Urology

St Louis, Missouri, 63110, United States

Location

Pediatric Urology Associates, PC

Tarrytown, New York, 10591, United States

Location

McKay Urology Carolinas Medical Center

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Cincinnati Children's Hospital Medical Center Cincinnati Center for Clinical Research and Outpatient Clinic

Cincinnati, Ohio, 45229, United States

Location

Oklahoma Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Children's Hospital of Wisconsin Department of Pediatric Urology

Milwaukee, Wisconsin, 53226, United States

Location

UZ Antwerpen

Antwerp, 2650, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

Location

CHU Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Hopital Pellegrin - Enfants

Bordeaux, 33076, France

Location

CHU de Limoges - Hôpital Mère et l'Enfant

Limoges, 87000, France

Location

Hôpital Necker Enfants-Malades

Paris, 75015, France

Location

Seconda Università di Napoli

Naples, 80138, Italy

Location

Bambin Gesù- Ospedale Pediatrico

Rome, 00165, Italy

Location

Copernicus Podmiot Leczniczy Sp. z o. o. Kliniczny Oddział Chirurgii i Urologii Dzieci i Młodzieży GUMed

Gdansk, 80-803, Poland

Location

Specjalistyczny Gabinet Lekarski

Poznan, 61-512, Poland

Location

Medical University of Wroclaw

Wroclaw, 50-369, Poland

Location

University of Ankara

Ankara, 6100, Turkey (Türkiye)

Location

Related Links

• More Information

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Brenda Jenkins

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 13, 2013
• Study Start: January 11, 2014
• Primary Completion: November 22, 2018
• Study Completion: October 3, 2019
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-04

Locations

TU (1); CZ (2); FR (3); CA (2); BE (3); US (14); IT (2); PL (3)