Study of BOTOX Injections to Assess Change in Disease Activity and Adverse Events in Adult Female Participants With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Allergan

Status and phase: Active, not recruiting; Phase 2

Conditions: Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Treatments: Drug: Placebo for BOTOX; Drug: BOTOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT05141006

M21-459

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms for at least 6 months, diagnosed by the investigator as IC/BPS, and confirmed dominant bladder derived pain.

Exclusion criteria

• History or current diagnosis of Hunner Lesions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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83 participants in 2 patient groups, including a placebo group

BOTOX

Experimental group

Description:

Participants will receive BOTOX on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24.

Treatment:

Drug: BOTOX

Placebo

Placebo Comparator group

Description:

Participants will receive placebo on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24.

Treatment:

Drug: BOTOX

Drug: Placebo for BOTOX