Trial reportJournal of diabetes investigation2020
Long-term safety and efficacy of mirogabalin in Asian patients with diabetic peripheral neuropathic pain.
Trial report in Journal of diabetes investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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.
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.
Who cites it
22 citing papers in PubMed, 48 citations in OpenAlex.
- First-In-Human Study of Mirogabalin (BM2216) Sustained-Release Tablets: Safety, Tolerability, Pharmacokinetics, Food Effect and Dose Proportionality With Comparison to Mirogabalin Besylate in Healthy Participants.Diabetes, obesity & metabolism · 2026Trial
- Trial
- Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study).BMC cancer · 2023Trial
- Long-term safety and efficacy of mirogabalin in Asian patients with diabetic peripheral neuropathic pain.Journal of diabetes investigation · 2020Trial
- Long-Term Efficacy and Safety of Treatments for Chronic Peripheral Neuropathic Pain: A Systematic Review and Narrative Synthesis.Pain and therapy · 2026Review
- Real-World Safety and Effectiveness of Mirogabalin in Chinese Adults with Diabetic Peripheral Neuropathic Pain: a Protocol of ReMIssion Study.Pain and therapy · 2026Article
- Long-Term Safety and Efficacy of Crisugabalin for Diabetic Peripheral Neuropathic Pain: A 52-Week, Multicenter, Single-Arm Trial.Journal of diabetes research · 2026Article
- The pivotal role of immunometabolism in diabetic neuropathy and its potential therapeutic strategies.Frontiers in endocrinology · 2026Review
- 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
- Calcium Channel αPain and therapy · 2025Review
- Efficacy and Safety of CaPain and therapy · 2025Review
- Short-term clinical outcomes of mirogabalin for carpal tunnel syndrome: A single-center retrospective pilot study.Journal of orthopaedics · 2025Article
- Mirogabalin as a novel calcium channel αFrontiers in pharmacology · 2024Review
- Effect of Hesperidin on Sciatic Nerve Damage in STZ-Induced Diabetic Neuropathy: Modulation of TRPM2 Channel.Neurotoxicity research · 2023Article
- Long-Term Safety and Efficacy of Mirogabalin for Central Neuropathic Pain: A Multinational, Phase 3, 52-Week, Open-Label Study in Asia.Pain and therapy · 2023Article
- The Clinical Application and Progress of Mirogabalin on Neuropathic Pain as a Novel Selective Gabapentinoids.Mediators of inflammation · 2023Review
- The Evidence for Effective Inhibition ofInternational journal of molecular sciences · 2022Article
- Mirogabalin as a Novel Gabapentinoid for the Treatment of Chronic Pain Conditions: An Analysis of Current Evidence.Anesthesiology and pain medicine · 2021Review
- Mirogabalin treatment of postoperative neuropathic pain after thoracic surgery: study protocol for a multicenter, randomized, open-label, parallel-group, interventional trial.Journal of thoracic disease · 2021Article
- Therapeutic Effect of Mirogabalin on Peripheral Neuropathic Pain due to Lumbar Spine Disease.Asian spine journal · 2021Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
Abstract
AIMS/
introductionDiabetic peripheral neuropathic pain (DPNP) affects the functionality, mood and sleep patterns of patients with diabetes. Mirogabalin, an α MATERIAL AND
methodsThis 52-week open-label extension study was carried out in Japan, Korea and Taiwan in patients with DPNP. Patients received mirogabalin, initiated at 5 mg twice daily and increased to a flexible maintenance dosage of 10 or 15 mg twice daily. Adverse events were monitored throughout the study. Patients provided a self-assessment of pain using the Short-Form McGill Pain Questionnaire.
resultsOf the 214 patients who entered the study, 172 (80.4%) completed the extension study. Of 172 patients who completed the study, 149 received the highest dosage of mirogabalin (15 mg twice daily). The most common treatment-emergent adverse events were nasopharyngitis, diabetic retinopathy, peripheral edema, somnolence, diarrhea, increased weight and dizziness. Most treatment-emergent adverse events were mild or moderate in severity. The incidence of treatment-emergent adverse events leading to treatment discontinuation was 13.1%. The visual analog scale and all other Short-Form McGill Pain Questionnaire subscales (sensory score, affective score, total score and present pain intensity) generally decreased over time from baseline until week 52.
conclusionsThis extension study showed the safety and efficacy of a long-term flexible dosing regimen of mirogabalin 10 or 15 mg twice daily in patients with DPNP.
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Registered trials
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.