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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)

Sponsor
Allergan (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05141006
Collaborator
(none)
80
Enrollment
40
Locations
2
Arms
19.4
Anticipated Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 Unites States.

Participants will receive BOTOX or placebo injected into the bladder on Day 1 and followed for at least 12 weeks in treatment 1. Eligible participants may request additional dose of BOTOX between Weeks 12 and 24 and 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Arm Study to Assess the Safety and Efficacy of a Single Treatment of BOTOX, Followed by an Optional Open-Label Treatment With BOTOX, in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Actual Study Start Date :
Mar 29, 2022
Anticipated Primary Completion Date :
Mar 13, 2023
Anticipated Study Completion Date :
Nov 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: BOTOX

Participants will receive BOTOX on Day 1 and 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.

Drug: BOTOX
Injection into the bladder
Other Names:
  • OnabotulinumtoxinA
  • Botulinum Toxin Type A

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo on Day 1 and 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.

    Drug: BOTOX
    Injection into the bladder
    Other Names:
  • OnabotulinumtoxinA
  • Botulinum Toxin Type A

    • Drug: Placebo for BOTOX
    Injection into the bladder

    Outcome Measures

    Primary Outcome Measures

    1. Change in Average Daily Worst Bladder Pain [Baseline (Week 0) to Week 6]

      Daily worst bladder pain will be assessed on the 11-point (0-10) numeric rating scale where 0 = no pain and 10 = the worst pain possible.

    Secondary Outcome Measures

    1. Change in the Average Number of Micturition Episodes per 24-hour Period [Baseline (Week 0) to Week 6]

      Micturition (whether participant was able to urinate) episodes will be collected on the 3-day bladder diary.

    2. Change in the Average Number of Urgency Episodes per 24-hour Period [Baseline (Week 0) to Week 6]

      Urgency episode will be collected on the 3-day bladder diary.

    3. Change in the Average Number of Nocturia Episodes per 24-hour Period [Baseline (Week 0) to Week 6]

      Nocturia episodes will be collected on the 3-day bladder diary.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology Centers of Alabama /ID# 243600 Homewood Alabama United States 35209
    2 Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002 Mobile Alabama United States 36608
    3 University of California, Los Angeles /ID# 245131 Los Angeles California United States 90095
    4 UCSD Medical Center /ID# 244935 San Diego California United States 92103-8620
    5 Cedars-Sinai Medical Center-West Hollywood /ID# 245786 West Hollywood California United States 90048
    6 Women's Health Connecticut, Inc - Women's Health Specialty Care - Farmington /ID# 241037 Farmington Connecticut United States 06032-1943
    7 Medstar Health Research Institute /ID# 245371 Washington District of Columbia United States 20010
    8 Manatee Medical Research Institute /ID# 243859 Bradenton Florida United States 34205-8626
    9 Clinical Research Center FL /ID# 243961 Pompano Beach Florida United States 33060
    10 Regional Urology LLC /ID# 241034 Shreveport Louisiana United States 71106
    11 Bay State Clincial Trials, Inc /ID# 240848 Watertown Massachusetts United States 01890
    12 Sheldon Freedman MD, ltd /ID# 241003 Las Vegas Nevada United States 89144
    13 Western New York Urology Associates - Harlem Professional Park /ID# 241036 Cheektowaga New York United States 14225-2591
    14 North Shore University Hospital /ID# 242594 New Hyde Park New York United States 11040
    15 New York University, Langone Health /ID# 241090 New York New York United States 10017
    16 Columbia University Medical Center /ID# 241086 New York New York United States 10032-3729
    17 Columbia University Medical Center /ID# 241087 New York New York United States 10032-3729
    18 Crystal Run Healthcare - Warwick /ID# 241116 Warwick New York United States 10990-4105
    19 FirstHealth Urogynecology /ID# 248584 Hamlet North Carolina United States 28345-4566
    20 Wake Forest University Baptist School of Medicine /ID# 240989 Winston-Salem North Carolina United States 27103
    21 The Christ Hospital /ID# 244800 Cincinnati Ohio United States 45219
    22 Univ Hosp Cleveland /ID# 247228 Cleveland Ohio United States 44106
    23 Wright State Physicians Obstetrics and Gynecology /ID# 241112 Oakwood Ohio United States 45409-1980
    24 The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown /ID# 241012 Allentown Pennsylvania United States 18103-3691
    25 MidLantic Urology /ID# 240997 Bala-Cynwyd Pennsylvania United States 19004
    26 Thomas Jefferson University /ID# 243703 Philadelphia Pennsylvania United States 19107-4414
    27 Magee-Womens Hospital of UPMC /ID# 245287 Pittsburgh Pennsylvania United States 15213-3108
    28 Medical University of South Carolina /ID# 242780 Charleston South Carolina United States 29425
    29 Chattanooga Medical Research /ID# 241092 Chattanooga Tennessee United States 37404
    30 Urology Associates PC - Nashville /ID# 242914 Nashville Tennessee United States 37209-4035
    31 University of Texas Southwestern Medical Center /ID# 244931 Dallas Texas United States 75390-7208
    32 Houston Methodist Research Institute /ID# 244929 Houston Texas United States 77030-2602
    33 Advances in Health, Inc. /ID# 240850 Houston Texas United States 77030
    34 Potomac Urology - Alexandria /ID# 243963 Alexandria Virginia United States 22311-1735
    35 Specialists For Women - Hillpoint /ID# 242541 Suffolk Virginia United States 23434-7181
    36 Urology of Virginia /ID# 240843 Virginia Beach Virginia United States 23462
    37 Southern Alberta Institute of Urology /ID# 244046 Calgary Alberta Canada T2V 1P9
    38 Queen's University /ID# 243972 Kingston Ontario Canada K7L 3J7
    39 Sunnybrook Health Sciences Ctr /ID# 243243 Toronto Ontario Canada M4N 3M5
    40 CHUS - Hopital Fleurimont /ID# 244058 Sherbrooke Quebec Canada J1H 5N4

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: ALLERGAN INC., Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT05141006
    Other Study ID Numbers:
    • M21-459
    First Posted:
    Dec 2, 2021
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Allergan
    Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
    BOTOX
    Botulinum Toxin Type A
    OnabotulinumtoxinA
    Additional relevant MeSH terms:
    Cystitis
    Cystitis, Interstitial
    Syndrome
    Somatoform Disorders
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Aug 24, 2022