Evidence map›Paper›PMID 40216732›Full record

ArticlePain and therapy2025

Efficacy and Safety of Mirogabalin in Patients with Neuropathic Pain Due to Cervical Spondylotic Radiculopathy: Miro-Cens, A Randomized, Controlled, Interventional Study.

Takashi Hirai, Atsushi Okawa, Hiroshi Takahashi, Kazuhito Shiosakai, Toshitaka Yoshii, Miro-Cens investigators

Abstract read
In one paragraph

Article in Pain and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Takashi HiraiDepartment of Orthopedic Surgery, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. hirai.orth@tmd.ac.jp.
Atsushi OkawaDepartment of Orthopedic Surgery, Yokohama City Minato Red Cross Hospital, Yokohama, Japan.
Hiroshi TakahashiPrimary Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Kazuhito ShiosakaiData Intelligence Department, Global DX, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Toshitaka YoshiiDepartment of Orthopedic Surgery, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
Miro-Cens investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere are few studies of pharmacotherapy of neuropathic pain in cervical spondylotic radiculopathy (CSR). Miro-Cens aimed to examine the efficacy and safety of mirogabalin for treating pain in patients with CSR on non-steroidal anti-inflammatory drugs (NSAIDs), compared with NSAIDs alone.

methodsMiro-Cens was a 12-week, multicenter, randomized, controlled, open-label, interventional study in Japan. Eligible patients with CSR having upper limb pain (visual analog scale score ≥ 40 mm) were randomly assigned in a 1:1 ratio to the mirogabalin add-on to NSAIDs group and the NSAIDs alone group. The primary endpoint was the change in the weekly average numerical rating scale (NRS) score for upper limb pain from baseline at Week 12.

resultsThe mirogabalin add-on group and NSAIDs alone group included 72 and 70 patients, respectively. The mirogabalin add-on group had a significantly greater reduction in the NRS score for upper limb pain than the NSAIDs alone group: estimated changes from baseline at Week 12, - 2.63 [95% confidence interval (CI) - 3.14, - 2.11] in the mirogabalin add-on group; - 1.07 (- 1.62, - 0.53) in the NSAIDs alone group; intergroup difference, - 1.55 (- 2.31, - 0.80; p < 0.001). The responder rate on the NRS score at Week 12 was significantly higher in the mirogabalin add-on group than in the NSAIDs alone group: ≥ 30% improvement, 71.7% vs. 39.6%; ≥ 50% improvement, 58.3% vs. 22.6% (both p < 0.001). The frequent treatment-emergent adverse drug reactions in the mirogabalin add-on group were the known ones (somnolence and dizziness), with most being mild or moderate in severity.

conclusionIn patients with CSR, combination therapy with mirogabalin and NSAIDs significantly improved neuropathic pain compared with NSAID monotherapy. No new safety concerns were identified, although caution should be exercised regarding somnolence and dizziness. These findings suggest that concomitant use of mirogabalin with NSAIDs could be tolerable and a novel treatment option for CSR patients with insufficient analgesic effects on NSAIDs. TRIAL REGISTRATION NUMBER: jRCTs031210629.

Indexed as

Cervical spondylotic radiculopathyGabapentinoidMirogabalinNeuropathic painNSAIDRandomized, controlled, interventional studyα2δ ligand

Identifiers

PMID40216732
PMCPMC12085725

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.