Miro-Hers

JRCT ID: jRCTs061220102

Registered date:27/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neuropathic pain caused by lumbar disc herniation
• Date of first enrollment: 15/03/2023
• Target sample size: 180
• Study type: Interventional
• Intervention(s): Comparing a lumbar disc herniation patient group taking mirogabalin add-on therapy to NSAIDs with a group taking NSAIDs monotherapy.

Outcome(s)

• Primary Outcome: Change in lower limb pain NRS (Numerical Rating Scale; 11-point scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain) from baseline to 1, 2, 4, and 8 weeks

Secondary Outcome

1. Change in sleep disturbance NRS from baseline to 1, 2, 4, and 8 weeks
2. Change in low back pain NRS from baseline to 1, 2, 4, and 8 weeks
3. Change in Japanese Orthopaedic Association JOABPEQ score (lower limb motor function, QOL) from baseline to 2 and 8 weeks
4. Time course of EQ-5D-5L score and health condition VAS at each point of from baseline to 2 and 8 weeks
5. Time course of Neuropathic Pain Symptom Inventory (NPSI) score at each point of form baseline to 2 and 8 weeks
6. Patient Global Impression of Change (PGIC) at 8 weeks
7. Time to 30% improvement in lower limb pain NRS
8. Area Under the Curve (AUC) of lower limb pain NRS
9. 30% responder rate and 50% responder rate at 8 weeks for lower limb pain VAS

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Suzuki Hidenori
• Source(s) of Monetary Support: Daiichi Sankyo Co., Ltd