Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

NCT00575016 | Terminated Phase 2 Results

• 1 other identifier: 191622-518
• Study Type: interventional
• Target: 74
• Locations: 6 countries
• Sites: 6

Brief Summary

The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

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 (2)

• Change From Baseline in Maximum Cystometric Capacity (MCC)

  Baseline, Week 6

• Change From Baseline in Maximum Detrusor Pressure (MDP)

  Baseline, Week 6

Study Arms (4)

1

EXPERIMENTAL

botulinum toxin Type A (50U); botulinum toxin Type A (200U)

Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)

2

EXPERIMENTAL

botulinum toxin Type A (100U); botulinum toxin Type A (200U)

Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)

3

EXPERIMENTAL

botulinum toxin Type A (200U)

Biological: botulinum toxin Type A (200U)

4

OTHER

placebo; botulinum toxin Type A (200U)

Biological: Normal saline (Placebo); botulinum toxin Type A (200U)

Interventions

Normal saline (Placebo); botulinum toxin Type A (200U) BIOLOGICAL

Placebo injection on Day 1 and botulinum toxin Type A injection 200 U \> Week 12; injection into the detrusor

Also known as: BOTOX®

4

botulinum toxin Type A (50U); botulinum toxin Type A (200U) BIOLOGICAL

botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

Also known as: BOTOX®

1

botulinum toxin Type A (100U); botulinum toxin Type A (200U) BIOLOGICAL

botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

Also known as: BOTOX®

2

botulinum toxin Type A (200U) BIOLOGICAL

botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

Also known as: BOTOX®

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Allergan: lead

Study Sites (6)

Unknown Facility

Cairo, Egypt

Location

Unknown Facility

Thessaloniki, Greece

Location

Unknown Facility

Ahmadābād, India

Location

Unknown Facility

Beirut, Lebanon

Location

Unknown Facility

Belgrade, Serbia

Location

Unknown Facility

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Saline Solution; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; 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)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; 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

Limitations and Caveats

Due to recruitment difficulties, study enrollment was stopped early.

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: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: December 13, 2007
• First Posted: December 17, 2007
• Study Start: December 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 2, 2015
• Results First Posted: October 17, 2011

Record last verified: 2015-09

Locations

EG (1); TU (1); GR (1); LE (1); SE (1); IN (1)