Mirogabalin Plus EBMP for IC/BPS

NCT07803393 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 2026YJSKTPG-03
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn whether adding mirogabalin to educational-behavioral modification program (EBMP) improves symptoms and safety outcomes for adults living with interstitial cystitis/bladder pain syndrome (IC/BPS). The main questions this study aims to answer are:

• Receive either standard EBMP alone or EBMP plus oral mirogabalin for 12 weeks
• Follow a flexible mirogabalin dosing schedule in the combination group, starting at a low dose and gradually increasing based on individual tolerance
• Complete regular clinic visits, bladder diaries, and symptom questionnaires at baseline, week 2, week 6, and week 12
• Undergo repeated assessments of pain, bladder function, quality of life, sleep status, and mood during treatment This is an open-label study, meaning participants and treating clinicians know the assigned treatment. To avoid assessment bias, outcome evaluators remain blinded to group allocation throughout the trial. The primary study outcome is participants' overall symptom response after 12 weeks of treatment. Secondary outcomes include changes in bladder pain, urinary frequency, functional bladder capacity, IC/BPS-specific symptoms, quality of life, sleep quality, and depressive symptoms. The study also monitors all adverse events to evaluate treatment safety over 12 weeks.

Conditions

Bladder Pain Syndrome; Educational Behavioral Intervention; Urinary Urgency

Outcome Measures

Primary Outcomes (1)

• 1. Proportion of Treatment Responders Assessed by Global Response Assessment (GRA)

  The 7-point patient-reported GRA scale evaluates overall treatment well-being, with response categories: markedly worse, moderately worse, slightly worse, unchanged, slightly improved, moderately improved, markedly improved. Participants reporting moderately improved or markedly improved outcomes are defined as treatment responders. We compare responder proportions between the two randomized groups.

  12 weeks after intervention initiation

Secondary Outcomes (4)

• 2. Changes in Pelvic Pain and Urgency/Frequency (PUF) Scale Scores

  Time Frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12

• Changes in ICSI score

  Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12

• Incidence and Severity Grading of Adverse Events

  Entire study period with assessments at Day 0, Week 1, Week 3, Week 5, Week 6, Week 12

• Changes in ICPI score

  Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12

Study Arms (2)

Arm1: EBMP Only Group

OTHER

Behavioral：Educational-Behavioral Modification Program (EBMP)

Behavioral: Behavioral: Educational and Behavioral Management Program (EBMP)

Arm 2：EBMP + Mirogabalin group

EXPERIMENTAL

Oral, starting dose 5 mg twice daily (Bid). Titrate by 5 mg Bid every week up to maximum 15 mg Bid, based on tolerability. Maintain the maximum tolerated dose (MTD) for total 12-week treatment. Dose reduction permitted for intolerable adverse events.

Drug: Intervention

Interventions

Behavioral: Educational and Behavioral Management Program (EBMP) BEHAVIORAL

Description: Standardized educational and behavioral intervention for IC/BPS patients, including bladder health education, dietary adjustment guidance, pelvic floor behavioral training, lifestyle modification and regular follow-up counseling. Identical EBMP content is delivered to participants in both study arms throughout the 12-week trial period.

Arm1: EBMP Only Group

Intervention DRUG

Oral, starting dose 5 mg twice daily (Bid). Titrate by 5 mg Bid every week up to maximum 15 mg Bid, based on tolerability. Maintain the maximum tolerated dose (MTD) for total 12-week treatment. Dose reduction permitted for intolerable adverse events.

Arm 2：EBMP + Mirogabalin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed with bladder pain syndrome/interstitial cystitis (IC/BPS) in accordance with diagnostic criteria released by AUA and ESSIC, with confounding disorders excluded through clinical workup
• Persistent urinary symptoms across most days in the latest 3 months prior to enrollment
• Participants report bladder pain/discomfort and urinary urgency/frequency scores ≥ 3 on the 0-10 Likert scale over the past 4 weeks

You may not qualify if:

• Active neurological diseases that impair bladder or intestinal function
• Active autoimmune disorders or infectious diseases
• History of cystitis secondary to tuberculosis, pelvic radiotherapy or pelvic chemotherapy
• Previous history of non-cutaneous malignant tumors
• Confirmed severe psychiatric disorders at present, including major depressive disorder, bipolar disorder, schizophrenia and other serious mental illnesses
• Severe systemic diseases featuring obvious dysfunction of the heart, lung, liver or kidney
• Confirmed hypersensitivity to pregabalin
• Concomitant use of additional antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs)
• Pregnancy status
• Lactation period

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Methods

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Fang Luo doctor, doctor

CONTACT

+8615560392365; Litypacop@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dotocr

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-08