SUMMARY: Investigators are recruiting 408 people with MS and urinary incontinence for a phase III trial to determine the safety and effectiveness of Dysport®
(abobotulinumtoxinA, Ipsen) injections for improving bladder muscle dysfunction. The study is funded by Ipsen.
: Botulinum is a powerful neurotoxin that temporarily blocks connections between the nerves and muscles, resulting in short-term relaxation of the targeted muscle. Dysport contains botulinum toxin type A. Dysport was approved by the U.S. Food and Drug Administration for the treatment of upper limb spasticity (extreme tightness) in adults, and lower limb spasticity in adults and children; these conditions affect people with MS. A previous study showed benefits for Dysport in treating urinary incontinence resulting from overactivity of the bladder detrusor muscle. and this study is intended to provide evidence confirming the safety and effectiveness of Dysport for this indication.
A similar agent, Botox®
(onabotulinumtoxin A, Allergan), is approved by the FDA to treat urinary incontinence resulting from overactivity of the bladder detrusor muscle, in addition to upper and lower limb spasticity. Dysport differs from Botox in that it takes less time to affect symptoms and affects a wider area.
Eligibility and Details
: Participants should be between ages 18 and 80, and diagnosed with multiple sclerosis. They should have had urinary incontinence for at least three months prior to screening that has not responded to at least four weeks of oral medications. Further enrollment criteria are available from the contact below.
Participants will be randomly assigned to receive 600 units of Dysport via injection into the bladder detrusor muscle, 800 units, or inactive placebo and will be followed for 104 to 116 weeks. Participants may receive multiple injections, with a minimum of 12 weeks between injections.
The primary outcome is to determine the change in weekly number of urinary incontinence episodes, as measured by a seven-day bladder diary. Secondary outcomes include safety and incontinence quality of life.
: To find out if you are eligible to participate, please click here
for a pre-screening questionnaire. For questions, please contact firstname.lastname@example.org
Sites are enrolling in the following cities:
Albuquerque, New Mexico
Bronx, New York
Charlotte, North Carolina
Des Moines, Iowa
Laguna Hills, California
Long Beach, California
Los Angeles, California
Mountlake Terrace, Washington
New York, New York
New York, New York
Owings Mill, Maryland
Palo Alto, California
Plainview, New York
Voorhees, New Jersey
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Without participants in research studies, MS research would come to a standstill. Read more here
Dysport is a registered trademark of Ipsen
Botox is a registered trademark of Allergan