Miro-Cens

Not Applicable

• Conditions: Peripheral Neuropathic Pain caused by Cervical Spondylotic Radiculopathy

• Registration Number: JPRN-jRCTs031210629
• Lead Sponsor: Hirai Takashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-25
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

[First stage enrollment (Screening)]
1.Patients diagnosed with cervical spondylotic radiculopathy at enrollment (separate diagnostic criteria are set)
2.Patients with upper limb pain associated with cervical spondylotic radiculopathy and continuing pain for more than 3 months before enrollment
3.Patients with a VAS value of 40 mm or more for upper limb pain at enrollment
4.Patients aged 20 years or older at the time of obtaining informed consent
5.Patients who can understand the procedure of this study, can answer Japanese questions appropriately without assistance, and can give their own written consent at their own free will to participate in the study

[Second stage enrollment (Randomization)]
1.Patients who have been continuously taking NSAIDs for at least 28 days prior to enrollment and have not changed dosage during that time
2.Patients with documented upper limb pain NRS for at least 4 days in the 7 days prior to enrollment and the average value of at least 4

Exclusion Criteria

[First stage enrollment (Screening)]
1.Patients with severe pain other than cervical spondylotic radiculopathy at enrollment and considered difficult to assess
2.Patients with a diagnosis of cervical spondylotic myelopathy at enrollment
3.Patients with a history of surgery of the cervical spine at enrollment
4.Patients with creatinine clearance (CLcr) <30 mL/min at enrollment
5.Patients with a history of hypersensitivity to components of mirogabalin, pregabalin, and gabapentin
6.Patients with a complicated malignancy who are under treatment or to have surgery during study period at enrollment
7.Patients with complicated infections and considered to have an impact on the evaluation in this study
8.Patients with complicated painful fractures
9.Patients with complicated serious liver, kidney, and heart disease who are difficult to participate in this study
10.Patients taking mirogabalin within 28 days before obtaining informed consent
11.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 intend to become pregnant within 6 months after obtaining informed consent
12.Patients who have at least 11 points for physicians, or at least 10 points for physicians and at least 15 points for patients on the Brief Scale for psychiatric problems in orthopaedic patients (BS-POP) at enrollment
13.Patients participating in or planned to participate in other intervention studies at enrollment
14.Other patients judged by the principal investigator or subinvestigator to be ineligible for participation in this study

[Second stage enrollment (Randomization)]
1.Patients with severe pain other than cervical spondylotic radiculopathy at enrollment and considered difficult to assess
2.Patients taking prohibited concomitant medications within 14 days before enrollment
3.Patients receiving prohibited concomitant therapy within 14 days before enrollment
4.Other patients judged by the principal investigator or the subinvestigator to be ineligible for participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 1-week average for upper limb pain NRSs (Numerical Rating Scale; 11-point rating scales from 0 to 10, with 0 for no pain and 10 for worst pain imaginable) from baseline (Visit 2:1 week earlier) to 12 weeks later (Visit 5:1 week earlier)

Secondary Outcome Measures

Name	Time	Method
1.Responder rates (>=30% reduction, >=50% reduction) at 12 weeks at the 1-week average for upper limb pain NRS<br>2.Change in upper limb pain VASs (Visual Analog Scale; rating scale of 100 mm, with 0 mm for no pain and 100 mm for worst pain imaginable) from baseline (Visit 2) to Visit 5<br>3.Change in 1-week average of the sleep disturbance NRS (Numerical Rating Scale; 11-point rating scale from 0 to 10, with no interference with sleep at all due to pain to 0 and no pain to 10) from baseline (Visit 2:1 week earlier) to 12 weeks (Visit 5:1 week earlier)<br>4.Change in Japanese Orthopaedic Association (JOA) CMEQ scores (cervical spine function, upper limb motor function, lower limb motor function, bladder function, and QOL) from baseline (Visit 2) to Visit 5<br>5.Time course of EQ-5D-5L scoring (Visit 2, Visit 3, Visit 4, Visit 5)<br>6.Time course of Neuropathic Pain Symptom Inventory (NPSI) Scoring (Visit 2, Visit 5)<br>7.Patient Global Impression of Change (Visit 5)