BOTOX Injections for Bladder Pain Syndrome
(IC/BPS POC Trial)
Trial Summary
What is the purpose of this trial?
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse events and change in disease symptoms will be evaluated.BOTOX (onabotulinumtoxinA) is an investigational drug being developed for the treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Study doctors randomly assign the participants to 1 of 2 groups, called treatment arms, to receive BOTOX or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 80 female participants, aged 18 to 75 years, with a diagnosis of IC/BPS will be enrolled in approximately 40 sites in the United States and Canada.Participants will receive BOTOX or placebo injected into the bladder on Day 1 and will be followed for at least 12 weeks in treatment 1. Eligible participants may request additional dose of BOTOX between Weeks 12 and 24, and will be followed for 12 weeks in treatment period 2.There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for adult women aged 18-75 with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) who've had symptoms for at least 6 months. It's not open to those with a history or current diagnosis of Hunner Lesions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive BOTOX or placebo injected into the bladder and are followed for at least 12 weeks
Treatment Period 2 (Optional)
Eligible participants may request an additional dose of BOTOX between Weeks 12 and 24, followed by 12 weeks of follow-up
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BOTOX
- Placebo for BOTOX
BOTOX is already approved in European Union, United States, Canada for the following indications:
- Chronic migraine
- Involuntary muscle contractions or twitching
- Excessive sweating
- Increased saliva
- Overactive bladder
- Crow's Feet
- Glabellar Lines
- Facial Wrinkles
- Orbicularis Oculi
- Platysma Bands
- Chronic migraine
- Involuntary muscle contractions or twitching
- Excessive sweating
- Increased saliva
- Overactive bladder
- Crow's Feet
- Glabellar Lines
- Facial Wrinkles
- Orbicularis Oculi
- Platysma Bands
- Cervical Dystonia
- Blepharospasm
- Chronic Spasticity
- Bruxism
- Dystonia
- Headache
- Similar to those in the United States and European Union, specific details may vary
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Allergan
Lead Sponsor
Brent Saunders
Allergan
Chief Executive Officer since 2015
JD and MBA from Temple University
Dr. David Nicholson
Allergan
Chief Medical Officer since 2015
MD from Harvard Medical School