Trial intelligence / Profile preview

Mirabegron for Overactive Bladder in Multiple Sclerosis (MIRROR)

NCT02086188Phase 4

Key facts

Status: Completed
Start: May 2014
Primary completion: Apr 2019
Countries: 1
Sponsor: Theodore R. Brown
Modality: Small Molecules

Drugs: mirabegron
Conditions: overactive bladder (OAB)

Overview

Phase 4, randomised, double-blind trial in overactive bladder (OAB) comparing Mirabegron with Placebo (2 arms). Primary endpoint: Overactive Bladder Symptom Composite Score at 10 weeks. Started May 2014; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Mirabegron
Mirabegron 25mg daily, optional increase to 50mg at week 5
Placebo
Matching placebo daily

Who it enrols

Adult patients with Multiple Sclerosis and overactive bladder symptoms (urgency, frequency, or incontinence) who have discontinued antimuscarinics.

Endpoints

Primary

Overactive Bladder Symptom Composite Score10 weeks

Secondary

Overactive Bladder Symptom Composite Score at Titration5 weeks
Mean Number of Micturitions per Day10 weeks
Mean Number of Incontinence Episodes per Day10 weeks
Mean Volume Voided per Micturition10 weeks
Qualiveen Questionnaire10 weeks
Subject Global Impression10 weeks

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