Results of Mirogabalin Treatment for Diabetic Peripheral Neuropathic Pain in Asian Subjects: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study

Masayuki Baba, Masanori Kuroha, Shoichi Ohwada, Emiko Murayama, Norimitsu Matsui, Masayuki Baba, Masanori Kuroha, Shoichi Ohwada, Emiko Murayama, Norimitsu Matsui

Abstract

Introduction: Almost one-quarter of Asian patients with diabetes experience diabetic peripheral neuropathic pain (DPNP), which may be associated with moderate or severe levels of pain, insomnia, mood disorders, and worsened quality of life. Current treatments are generally ineffective and may be poorly tolerated. We evaluated mirogabalin as a treatment for DPNP in Asian subjects.

Methods: This phase 2, randomized, double-blind, controlled study was conducted in Japan, South Korea, and Taiwan. Subjects (n = 450) with DPNP were randomized (1:1:1:1:1) to treatment with 5, 10, or 15 mg twice-daily (BID) mirogabalin, 150 mg BID pregabalin, or placebo. The primary endpoint was change from baseline in average daily pain score (ADPS) at week 7; secondary endpoints included responder rates, Short-Form McGill Pain Questionnaire (SF-MPQ), Patient Global Impression of Change (PGIC), average daily sleep-interference score (ADSIS), and incidence of treatment-emergent adverse events (TEAEs).

Results: A greater improvement was noted for each mirogabalin treatment group for change from baseline in ADPS at week 7 compared with both placebo and with pregabalin, although these improvements were not statistically significant. The percentage of 30, 50, and 75% responders and subjects with PGIC improvements was greater in each mirogabalin group versus placebo. Mirogabalin 15 mg BID significantly improved the SF-MPQ sensory (p = 0.0313) and visual analog scale scores (p = 0.0093), and ADSIS (p = 0.0002), versus placebo. Treatment was generally well tolerated; the most frequently reported TEAEs in the mirogabalin groups were somnolence (14.7%) and dizziness (11.0%), and most AEs were mild or moderate even at the highest dose.

Conclusions: In Asian subjects with DPNP, mirogabalin (5, 10, and 15 mg BID) was well tolerated. Although no significant differences were observed in the primary endpoint, there was a tendency toward improvement of pain with mirogabalin treatment, and this trend was also observed in the secondary endpoints.

Trial registration: ClinicalTrials.gov identifier, NCT01504412.

Keywords: Clinical trial; Diabetic peripheral neuropathy; Mirogabalin; Pain management; Phase 2; Pregabalin.

Figures

Fig. 1
Fig. 1
Study design (a) and subject disposition (b). aAfter informed consent was obtained, subjects who were under treatment with the prohibited concomitant medications underwent a washout period of 7 days or more. BID twice daily, QD once daily
Fig. 2
Fig. 2
Time course of average daily pain scoresa (full analysis set). ADPS average daily pain score, BID twice daily, LOCF last observation carried forward, SD standard deviation. aArithmetic mean (SD). The baseline ADPS was defined as the average of up to seven available pain scores in the last 7 days at or before randomization

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Source: PubMed

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