Miro-Hers

Phase 4

Recruiting

• Conditions: europathic pain caused by lumbar disc herniation

• Registration Number: JPRN-jRCTs061220102
• Lead Sponsor: Suzuki Hidenori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Patients diagnosed with lumbar disc herniation by MRI imaging findings by the time of enrollment (Visit 1)
2. Patients with lower limb pain (including buttocks pain) with NRS of 4 or more due to neuropathic pain associated with lumbar disc herniation at the time of enrollment (Visit 1)
3.Patients on whom over 1 week have passed since the onset of lumbar disc herniation and are taking NSAIDs at the time of enrollment (Visit 1)
4.Patients aged 18 years or older at the time of obtaining informed consent
5.Patients who can correctly evaluate lower limb pain by distinguishing between low back pain and lower limb pain
6.Patients who can understand the procedure of this study, answer questions in Japanese appropriately in writing and by electromagnetic means (ePRO) without assistance, and give their own written consent on their own free will to participate in this study by writing or electromagnetic means (eConsent)

Exclusion Criteria

1.Patients with a period of 3 months or more from the onset of lower limb pain to the time of enrollment (Visit 1)
2.Patients with muscle weakness (Manual Muscle Testing; MMT<=3)*
*: tibialis anterior muscle (L4), extensor hallucis longus muscle (L5), gastrocnemius muscle (S1)
3.Patients with bladder and rectal disorders and scheduled for surgery during this study participation period
4.Patients with lower limb pain caused by disease other than lumbar disc herniation and considered difficult to be evaluated
5.Patients with severe pain caused by disease other than lumbar disc herniation and considered difficult to be evaluated
6.Patients scheduled for surgery that will affect the efficacy evaluation of lower limb pain caused by lumbar disc herniation
7.Patients with a history of lumbar spine surgery
8.Patients with creatinine clearance (CLcr) less than 30 mL/min
9.Patients with serious hepatic, renal, or cardiac disease
10.Patients who have taken prohibited concomitant medications within 7 days prior to enrollment (Visit 1)
11.Patients who have received prohibited concomitantly therapy within 7 days prior to enrollment (Visit 1)
12.Patients who have taken mirogabalin for lumbar disc herniation currently occurred
13.Patients taking mirogabalin for diseases other than lumbar disc herniation
14.Patients with a history of hypersensitivity to the ingredients of mirogabalin
15.Patients who are pregnant or possibly pregnant at the time of obtaining informed consent, patients who are breastfeeding at the time of obtaining informed consent, and patients who are planning to become pregnant within 6 months after obtaining informed consent
16.Patients participating in or scheduled to participate in other intervention studies at the time of enrollment
17.Other patients judged by the principal investigator or subinvestigator to be unsuitable for participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified