Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
This is a prospective, multicentre (7 sites), randomized, double-blind, study comparing
intravesical injection of BOTOX to placebo in 56 subjects with NDO secondary to spinal cord
injury or multiple sclerosis. Study subjects will be randomized to one of the following two
treatment groups:
Group 1 n=28 BOTOX - 300U Group 2 n=28 Placebo BOTOX (saline)
All study subjects will receive one injection cycle (BOTOX 300U or Placebo) at Visit 2
(Treatment, Day 0) as per Supplement III. The study duration is approximately 61 weeks and
consists of a Pre-Treatment Evaluation, a Treatment/Randomization Visit (Visit 2, Day 0),
Telephone Follow-ups at 1, 3 and 4 weeks post-treatment, and Follow-up Visits at 6, 24 and 36
weeks (Visits 3 to 5). At Week 36, subjects will be offered open-label BOTOX 300U and will be
followed for an additional 6 months, returning for evaluations at Weeks 48 and 60.
Phase:
Phase 3
Details
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborator:
ethica Clinical Research Inc.
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA