ArticlePain and therapy2023
Long-Term Safety and Efficacy of Mirogabalin for Central Neuropathic Pain: A Multinational, Phase 3, 52-Week, Open-Label Study in Asia.
Article in Pain and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03901352 (An Asian, Multicenter, Randomized, Double-blind, Placebo-controlled, 14-week Study of Mirogabalin in Participants With Central Neuropathic Pain Followed by a 52-week, Open-label Extension), which is not on this map. Cited by 12 papers.
What it found
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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.
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.
An Asian, Multicenter, Randomized, Double-blind, Placebo-controlled, 14-week Study of Mirogabalin in Participants With Central Neuropathic Pain Followed by a 52-week, Open-label Extension
Who cites it
12 citing papers in PubMed.
- Clinical Outcomes after Onset of Mirogabalin-Related Adverse Drug Reactions in Patients with Lumbar Spinal Stenosis: Post Hoc Analysis of the MiroTAS Study.Pain and therapy · 2026Article
- Predictors of a Gabapentinoid-Loop-Diuretic Prescribing Cascade in U.S. Nursing Home Residents.Journal of the American Geriatrics Society · 2026Article
- Post-marketing safety evaluation of mirogabalin using the JADER database.Frontiers in pharmacology · 2026Article
- Efficacy and Safety of CaPain and therapy · 2025Review
- Efficacy and Safety of Mirogabalin as an Add-on to Nonsteroidal Anti-inflammatory Drugs for Neuropathic Pain Caused by Lumbar Disc Herniation: A Randomized Controlled Study (Miro-Hers).Pain and therapy · 2025Article
- A Multicenter, Prospective, Observational, and Single-Arm Interventional Study of Mirogabalin in Diabetic Peripheral Neuropathic Pain: Rationale and Design of Dia-NeP.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
- Safety and Efficacy of Mirogabalin in Lumbar Spinal Stenosis Patients with Peripheral Neuropathic Pain on NSAIDs: Post Hoc Analysis of the MiroTAS Study.Pain and therapy · 2025Article
- Efficacy and Safety of Mirogabalin in Patients with Neuropathic Pain Due to Cervical Spondylotic Radiculopathy: Miro-Cens, A Randomized, Controlled, Interventional Study.Pain and therapy · 2025Article
- Usefulness of Mirogabalin in Central Neuropathic Pain After Stroke: Post Hoc Analysis of a Phase 3 Study by Stroke Type and Location.Pain and therapy · 2024Article
- Post-thoracotomy pain syndrome in the era of minimally invasive thoracic surgery.Journal of thoracic disease · 2024Review
- Mirogabalin as a novel calcium channel αFrontiers in pharmacology · 2024Review
- Novel drug treatments for pain in advanced cancer and serious illness: a focus on neuropathic pain and chemotherapy-induced peripheral neuropathy.Palliative care and social practice · 2024Review
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionCentral neuropathic pain (CNeP) is difficult to treat and has diverse etiology, including spinal cord injury (CNePSCI), Parkinson's disease (CNePPD), and central post-stroke pain (CPSP). The safety and efficacy of mirogabalin have been demonstrated in short-term trials, including patients with CNePSCI. The objective of our study was to confirm the safety/efficacy of mirogabalin in patients with CNePPD and CPSP, and obtain long-term data for CNePSCI.
methodsThis 52-week, open-label extension of a previous randomized controlled study was conducted across Japan, Korea, and Taiwan. Patients with CNePSCI, CNePPD, or CPSP received twice daily (BID) 5-10 mg mirogabalin for a 4-week titration period, after which the dosage was maintained for 47 weeks at a maximum of 15 mg BID, followed by a 1-week taper period receiving the same dose but only administered once daily. The primary endpoint was safety, assessed primarily by incidence and severity of treatment-emergent adverse events (TEAEs). Efficacy was assessed in a post hoc analysis of data obtained by the short-form McGill Pain Questionnaire (SF-MPQ).
resultsOf the 210 patients enrolled, 106, 94, and 10 had CNePSCI, CPSP, and CNePPD, respectively. The mean overall age of patients was 62.9 years, and most patients were male and of Japanese ethnicity. TEAEs occurred in 84.8% of patients, the most common being somnolence (16.7%), peripheral edema (12.4%), edema (11.4%), nasopharyngitis (11.0%), and dizziness (7.6%). Most TEAEs were mild. Severe and serious TEAEs occurred in 6.2% and 13.3% of patients, respectively. All patient groups experienced reductions in SF-MPQ visual analog scores for pain: mean ± standard deviation changes from baseline at week 52 were -2.3 ± 21.13 mm (CNePSCI), -17.0 ± 24.99 mm (CPSP), and -17.1 ± 35.32 mm (CNePPD).
conclusionMirogabalin was generally safe, well tolerated, and effective for treatment of CNeP in this long-term study.
trial registrationClinicalTrials.gov identifier, NCT03901352.
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