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Mirogabalin Plus EBMP for IC/BPS

NCT07803393 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-09-03

No results posted yet for this study

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:

1. Does combined mirogabalin and EBMP treatment produce better overall symptom improvement after 12 weeks compared with EBMP alone?
2. Is combination treatment safe and well-tolerated in adults with IC/BPS?

Researchers will compare two treatment groups to test these questions. Eligible adult participants will be randomly assigned in a 1-to-1 ratio to one of two groups. Randomization is performed through a certified online clinical trial platform with allocation concealment.

Participants will:

* 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

Interventions

BEHAVIORAL

Behavioral: Educational and Behavioral Management Program (EBMP)

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.

DRUG

Intervention

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.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-20
Primary Completion
2026-12-31
Completion
2027-02-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803393 on ClinicalTrials.gov