Administration of Mirabegron 50mg in patients with neurogenic bladder

A randomized, double blind, placebo controlled study to evaluate the efficacy and safety of mirabegron 50 mg versus placebo in patients with neurogenic detrusor overactivity - MIRAGE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002592-29-CZ

Enrollment

Registered

2014-12-29

Start date

2015-04-17

Completion date

Unknown

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal cord injury Multiple sclerosis

Interventions

Trade Name: Betmiga Product Name: Betmiga Pharmaceutical Form: Coated tablet INN or Proposed INN: mirabegron CAS Number: 223673-61-8 Other descriptive name: MIRABEGRON Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with the proved neurogenic detrusor overactivity NDO with complete or incomplete spinal cord injury or multiple sclerosis Symptoms of NDO stable of at least 6 month Patient able and willing to take the study medication according to the protocol Patient able and willing to attend all examinations according to the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 92 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with the NDO of other origin than studied Patients with symptomatic infection of urinary tract Patients with interstitial cystitis, stones Patients with bladder cancer or after radiation therapy in pelvis Patients with severe renal or hepatic impairement Patients with severe or nontreated hypertension

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Change of maximal cystometric capacity;Timepoint(s) of evaluation of this end point: V3 visit compaired to the baseline investigation;Main Objective: Exploration of the mirabegron 50mg efficacy compaired to placebo in patients with NDO;Secondary Objective: To assess the safety of the mirabegron 50mg compairing with the placebo in patients with NDO To assess the mirabegron 50mg effect against placebo on the quality of the life	—

Measure

Time frame

Primary end point(s): Change of maximal cystometric capacity;Timepoint(s) of evaluation of this end point: V3 visit compaired to the baseline investigation;Main Objective: Exploration of the mirabegron 50mg efficacy compaired to placebo in patients with NDO;Secondary Objective: To assess the safety of the mirabegron 50mg compairing with the placebo in patients with NDO To assess the mirabegron 50mg effect against placebo on the quality of the life

—

Secondary

Measure	Time frame
Secondary end point(s): Change in the volume of the nonvoiding contraction Change of the maximal detrusor pressure Change of the detrusor compliance Change in the 24hours pad-weight test Change in the i-QOL score Change in the PPBC score Change in the VAS TS score ;Timepoint(s) of evaluation of this end point: V3 visit compaired to the baseline investigation	—

Countries

Czech Republic

Contacts

Public ContactDepartment of Urology

University hospital Ostrava

jan.krhut@fno.cz+420597375301

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026