OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)

NCT02097121 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: 191622-1372014-000464-17
• Study Type: interventional
• Target: 56
• Locations: 13 countries
• Sites: 39

Brief Summary

This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.

Conditions

Urinary Incontinence; Urinary Bladder; Overactive

Outcome Measures

Primary Outcomes (1)

• 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 per the respective treatments that participants received in the corresponding treatment cycle.

  From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1

Secondary Outcomes (11)

• Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes

  From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1

• Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes

  From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1

• Percentage of Participants With Night Time Urinary Incontinence

  From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1

• Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)

  From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1

• Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)

  From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1

Other Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  From the first dose of study drug until the last dose, up to 147 weeks

Study Arms (3)

Botox 25 U

EXPERIMENTAL

Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Biological: BOTOX®

Botox 50 U

EXPERIMENTAL

Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Biological: BOTOX®

Botox 100 U

EXPERIMENTAL

Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Biological: BOTOX®

Interventions

BOTOX® BIOLOGICAL

Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.

Also known as: Botulinum Toxin Type A

Botox 100 U; Botox 25 U; Botox 50 U

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
• OAB symptoms not adequately managed by 1 or more anticholinergic agents

You may not qualify if:

• OAB caused by a neurological condition
• Use of anticholinergics or other medications to treat OAB symptoms within 7 days
• Current use of indwelling catheter or 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 within 3 months for any other condition or use
• Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

Sponsors & Collaborators

• Allergan: lead

Study Sites (39)

Alaska Urological Institute /ID# 238189

Anchorage, Alaska, 99503-3902, United States

Location

Arkansas Children's Hospital /ID# 237787

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital Colorado /ID# 237621

Aurora, Colorado, 80045, United States

Location

Yale New Haven Hospital - Yale School of Medicine /ID# 238222

New Haven, Connecticut, 06510-3206, United States

Location

Orlando Health-Arnold Palmer Hospital for Children Pediatric Urology /ID# 235283

Orlando, Florida, 32806, United States

Location

Associated Urologist of North Carolina /ID# 235437

Raleigh, North Carolina, 27612, United States

Location

Cook Children's Med. Center /ID# 237539

Fort Worth, Texas, 76104, United States

Location

Children's Hospital Wisconsin - Milwaukee Campus /ID# 237544

Milwaukee, Wisconsin, 53226, United States

Location

Sydney Children's Hospital /ID# 237191

Randwick, New South Wales, 2031, Australia

Location

The Children's Hospital at Westmead /ID# 234337

Sydney, New South Wales, 2145, Australia

Location

Monash Children's Hospital /ID# 234388

Clayton, Victoria, 3168, Australia

Location

Universitair Ziekenhuis Antwerpen /ID# 237997

Edegem, Antwerpen, 2650, Belgium

Location

UZ Gent /ID# 237588

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 237218

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Alberta Children's Hospital /ID# 237510

Calgary, Alberta, T3B 6A8, Canada

Location

London Health Sciences Center /ID# 234304

London, Ontario, N6A 5W9, Canada

Location

CHUS - Hopital Fleurimont /ID# 237668

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Fakultni nemocnice Olomouc /ID# 237577

Olomouc, 779 00, Czechia

Location

Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 237392

Bordeaux, 33076, France

Location

Hôpital de la Mère et de l'Enfant /ID# 235227

Limoges, 87042, France

Location

Hôpitaux Pédiatriques de Nice CHU-LENVAL /ID# 235278

Nice, 06200, France

Location

Evangelisches Krankenhaus Bielefeld /ID# 235234

Bielefeld, 33617, Germany

Location

Urologische Gemeinschaftspraxis /ID# 234978

Emmendingen, 79312, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 234288

Lübeck, 23538, Germany

Location

AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 237308

Napoli, 80138, Italy

Location

Radboud Universitair Medisch Centrum /ID# 237043

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Maastricht Universitair Medisch Centrum /ID# 237678

Maastricht, 6229 HX, Netherlands

Location

Oslo University Hospital /ID# 234434

Oslo, 0372, Norway

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 238166

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

Specjalistyczny Gabinet Lekarski /ID# 235257

Poznan, 61-512, Poland

Location

Medical Concierge Centrum Medyczne /ID# 235200

Warsaw, 02-798, Poland

Location

St Georges Hospital /ID# 235316

Port Elizabeth, 6001, South Africa

Location

Manchester University NHS Foundation Trust /ID# 234380

Manchester, Lancashire, M13 9WL, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 234819

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

NHS Greater Glasgow and Clyde /ID# 237430

Glasgow, Scotland, G12 0XH, United Kingdom

Location

NHS Grampian /ID# 237379

Aberdeen, AB15 6RE, United Kingdom

Location

Alder Hey Children's NHS Foundation Trust /ID# 237279

Liverpool, L12 2AP, United Kingdom

Location

Royal Berkshire NHS Foundation Trust /ID# 236915

Reading, RG1 5AN, United Kingdom

Location

Sheffield Children's NHS Foundation Trust /ID# 237854

Sheffield, S10 2TH, United Kingdom

Location

Related Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com.,To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.

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: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ALLERGAN INC.

  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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: May 23, 2014
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

Locations

GB (7); CA (3); AU (3); NL (2); DE (3); US (8); CZ (1); IT (1); BE (3); FR (3); NO (1); PL (3); ZA (1)