MiroTAS

JRCT ID: jRCTs021200007

Registered date:03/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lumber Spinal Stenosis
• Date of first enrollment: 19/06/2020
• Target sample size: 300
• Study type: Interventional

Intervention(s)

Comparison in the effect and safety of Mirogabalin add-on therapy to NSAIDs and NSAIDs monotherapy for patients with Lumber Spinal Stenosis and administrated of NSAIDs.
1) NSAIDs monotherapy as a study drug are prescribed in accordance with a package insert and each of their administration and dosage is not changed while a study drug is administrated.
2) Mirogabalin add-on therapy to NSAIDs: NSAIDs as a study drug are prescribed in accordance with a package insert and each of their administration and dosage is not changed while a study drug is administrated. Mirogabalin is prescribed as follows in accordance with renal function of a subject.
Patients with creatinine clearance more than 60mL/min: Mirogabalin is administrated in dose of 5mg twice a day at the first week. At the next week, Mirogabalin is administrated in dose of 10mg twice a day. At week 5(after Visit3), dose of Milogabalin is increased to 15mg twice a day unless there is no problem with the safety. After that, the dose of Mirogabalin is controlled by 10mg twice a day or 15mg twice a day depending on safety findings.
Patients with creatinine clearance 30-60mL/min: Mirogabalin is administrated in dose of 2.5mg twice a day at the first week. At the next week, Mirogabalin is administrated in dose of 5mg twice a day. At week 5(after Visit3), dose of Milogabalin is increased to 7.5mg twice a day unless there is no problem with the safety. After that, the dose of Mirogabalin is controlled by 5mg twice a day or 7.5mg twice a day depending on safety findings.
Also, more than 7 days washout period before enrollment is required for target patients administrated of prohibited drugs.
If the administration of Mirogabalin is discontinued, down-titration is needed in accordance with the insert package.

Outcome(s)

• Primary Outcome: 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

1. Amount of the changes of QOL scores from responses of the EQ-5D-5L.
2. PGIC

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nikaido Takuya
• Source(s) of Monetary Support: Daiichi Sankyo Co., Ltd
• Secondary ID(s): Nil known