Evidence map›Paper›PMID 30913164›Full record

Trial reportPain2019

Mirogabalin for the management of postherpetic neuralgia: a randomized, double-blind, placebo-controlled phase 3 study in Asian patients.

Jitsu Kato, Norimitsu Matsui, Yoshihiro Kakehi, Emiko Murayama, Shoichi Ohwada, Masahiro Sugihara

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pain, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02318719 (An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Post-herpetic Neuralgia Followed by a 52-Week Open-label Extension), which is not on this map. Cited by 56 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 4 pooled it
–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.

NCT02318719 nacompletednot on this map

An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Post-herpetic Neuralgia Followed by a 52-Week Open-label Extension

TypeinterventionalSponsorDaiichi Sankyo Co., Ltd.Ran2015 to 2017Enrolled765ConditionsPost-Herpetic NeuralgiaArmsPlacebo, DS-5565
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  15. A randomised, double-blind, placebo-controlled study to determine the analgesic efficacy, safety and tolerability of VPX638 administered topically to painful wounds.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Jitsu KatoDepartment of Anesthesiology, Nihon University School of Medicine, Tokyo, Japan.
Norimitsu MatsuiClinical Development Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.
Yoshihiro KakehiClinical Development Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.
Emiko MurayamaAsia Development Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.
Shoichi OhwadaBiostatistics and Data Management Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.
Masahiro SugiharaBiostatistics and Data Management Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study investigated the safety and efficacy of mirogabalin, a novel, potent, selective ligand of the α2δ subunit of voltage-dependent Ca channels, for the treatment of postherpetic neuralgia (PHN). In this multicenter, double-blind, placebo-controlled phase 3 study, Asian patients ≥20 years with PHN were randomized 2:1:1:1 to placebo or mirogabalin 15, 20, or 30 mg/day for up to 14 weeks (NCT02318719). The primary efficacy endpoint was the change from baseline in average daily pain score at week 14, defined as a weekly average of daily pain (0 = "no pain" to 10 = "worst possible pain," for the last 24 hours). Of 765 patients randomized, 763 received ≥ 1 dose of the study drug and were included in the analysis; 303, 152, 153, and 155 received placebo, mirogabalin 15, 20, or 30 mg/day, respectively. A total of 671 (87.7%) patients completed the study. At week 14, the difference in average daily pain score least squares mean vs placebo was -0.41, -0.47, and -0.77, respectively; all mirogabalin groups showed statistical significance. The most common treatment-emergent adverse events were somnolence, nasopharyngitis, dizziness, weight increase, and edema, and all of them were mild or moderate in severity. Mirogabalin was superior to placebo in all groups for relieving PHN and appeared well tolerated.

Indexed as

Asian PeopleAdolescentAdultAgedAnalgesicsBridged Bicyclo CompoundsDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansInternational CooperationMaleMiddle AgedNeuralgia, PostherpeticOutcome Assessment, Health CareAnalgesicsBridged Bicyclo Compoundsmirogabalin

Identifiers

PMID30913164
PMCPMC6485311

What OpenQuestion holds

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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.