NCT00311376

Brief Summary

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2006

Typical duration for phase_3

Geographic Reach
13 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 17, 2011

Completed
Last Updated

December 4, 2015

Status Verified

November 1, 2015

Enrollment Period

3.8 years

First QC Date

April 4, 2006

Results QC Date

September 9, 2011

Last Update Submit

November 5, 2015

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Number of Weekly Episodes of Urinary Incontinence

    Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

    Baseline, Week 6

Secondary Outcomes (3)

  • Change From Baseline in Maximum Cystometric Capacity (MCC)

    Baseline, Week 6

  • Change From Baseline in Maximum Detrusor Pressure (MDP)

    Baseline, Week 6

  • Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire

    Baseline, Week 6

Study Arms (4)

1

EXPERIMENTAL

botulinum toxin Type A (200U)

Biological: botulinum toxin Type A (200U)

2

EXPERIMENTAL

botulinum toxin Type A (300U)

Biological: botulinum toxin Type A (300U)

3

OTHER

placebo; botulinum toxin Type A (200U)

Other: Normal Saline (Placebo); botulinum toxin Type A (200U)

4

OTHER

placebo; botulinum toxin Type A (300U)

Other: Normal Saline (Placebo); botulinum toxin Type A (300U)

Interventions

botulinum toxin Type A (200U)BIOLOGICAL

botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval

Also known as: BOTOX®
1
botulinum toxin Type A (300U)BIOLOGICAL

botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at \> 12 weeks interval

Also known as: BOTOX®
2
Normal Saline (Placebo); botulinum toxin Type A (200U)OTHER

Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval

Also known as: BOTOX®
3
Normal Saline (Placebo); botulinum toxin Type A (300U)OTHER

Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at \> 12 weeks interval

Also known as: BOTOX®
4

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
  • Inadequate response to anticholinergic medication used to treat overactive bladder

You may not qualify if:

  • History of evidence of pelvic or urologic abnormality
  • Previous or current diagnosis of bladder or prostate cancer
  • Urinary tract infection at time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Royal Oak, Michigan, United States

Location

Unknown Facility

Randwick, New South Wales, Australia

Location

Unknown Facility

Innsbruck, Austria

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Sherbrooke, Canada

Location

Unknown Facility

Ostrava, Czechia

Location

Unknown Facility

Garches, France

Location

Unknown Facility

Halle, Germany

Location

Unknown Facility

Christchurch, New Zealand

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Martin, Slovakia

Location

Unknown Facility

Lviv, Ukraine

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (3)

  • Cuervo J, Castejon N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7.

    PMID: 25288099DERIVED

  • Chancellor MB, Patel V, Leng WW, Shenot PJ, Lam W, Globe DR, Loeb AL, Chapple CR. OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity. Neurology. 2013 Aug 27;81(9):841-8. doi: 10.1212/WNL.0b013e3182a2ca4d. Epub 2013 Jul 26.

    PMID: 23892704DERIVED

  • Ginsberg D, Gousse A, Keppenne V, Sievert KD, Thompson C, Lam W, Brin MF, Jenkins B, Haag-Molkenteller C. Phase 3 efficacy and tolerability study of onabotulinumtoxinA for urinary incontinence from neurogenic detrusor overactivity. J Urol. 2012 Jun;187(6):2131-9. doi: 10.1016/j.juro.2012.01.125. Epub 2012 Apr 12.

    PMID: 22503020DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type ASaline Solution

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Therapeutic area Head
Organization
Allergan, Inc.
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    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
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

April 4, 2006

First Posted

April 6, 2006

Study Start

August 1, 2006

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

December 4, 2015

Results First Posted

October 17, 2011

Record last verified: 2015-11

Locations

NZ(1)FR(1)CA(1)SL(1)BE(1)CZ(1)AU(1)DE(1)US(1)PL(1)RU(1)UA(1)GB(1)