MiroTAS

Not Applicable

• Conditions: umber Spinal Stenosis

• Registration Number: JPRN-jRCTs021200007
• Lead Sponsor: ikaido Takuya

Brief Summary

From this study, it was indicated that NSAIDs and mirogabalin combination therapy showed efficacy to the Lumbar Spinal Stenosis patients to whom pain management by NSAIDs monotherapy had been insufficient. Though it was necessary to pay attention to the occurrence of somnolence, dizziness, and so on when adding mirogabalin to NSAIDs, no difference was seen about frequency of AE occurrence in comparison with previous study, and no new concern was found about safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-03
• Study Completion: 2021-10-22
• Results First Posted: 2022-07-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1) Patients who have lower limb pain caused by nerve root-type Lumber Spinal Stenosis and can be judged that more than 3 months have passed since the occurrence of the pain has started. (Refer to Procedure for diagnosis of nerve root-type Lumber Spinal Stenosis for details.)
2) Patients who is administrated NSAIDS at the enrollment and have not changed dose for more than 4 weeks before the enrollment.
3) Patients with more 40mm of VAS for lower limb pain at informed consent and the enrollment.
4) Patients with 20 years old or older at the enrollment.
5) Patients who are able to understand the procedure of the clinical study, answer a question appropriately and give their voluntary written consent to participate in the study.

Exclusion Criteria

1) Patients who used prohibited drugs within 7 days before the enrollment of the study.
2) Patients who changed administration and dosage of limited drugs within 4 weeks before the enrollment of the study.
3) Patients who have severe pain caused by symptoms except for Lumber Spinal Stenosis and have difficulty being evaluated for the study.
4) Patients with cauda equina type or mixed-type Lumber Spinal Stenosis.
5) Patients who have past history of lumber spine surgery
6) Patients who have complication of cancer, infectious disease and fracture at the enrollment.
7) Patients who have past history of hypersensitivity to ingredients of Mirogabalin.
8) Patients who have difficulty participating in the study due to severe complication of liver disease, kidney disease and heart disease.
9) Pregnancy patients or patients who have possibility of pregnancy.
10) Patients with creatinine clearance less than 30mL/min by Cockroft-Gault Equation at enrollment
11) Patients with more than 11 points or 10 points in physician version of the Brief Scale for Psychiatric Problems in Orthopaedic Patients (BS POP) and also 15 points in patient version of BS POP.
12) Patients who are inappropriate for participation in the study for othe reason in the opinion of the investigator or sub-investigator.
13) Previous treatment with Mirogabalin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analogue scale of lower limb pain; Amount of the change of pain intensity(VAS providing a range scores from 0-100: no pain 0mm and the worst severe pain imaginable 100mm)from the enrollment(baseline) to at 12 weeks of the study.

Secondary Outcome Measures

Name	Time	Method
1. Amount of the changes of QOL scores from responses of the EQ-5D-5L.<br>2. PGIC