Table 1 Table showing studies in which mirogabalin was used in various chronic pain conditions
S. no. | No. of patients | Type of study | Indication | Dose used | Key points | Author/year/reference |
|---|---|---|---|---|---|---|
1 | 452 | Randomized, double-blind, placebo- and active comparator-controlled, adaptive proof-of-concept phase 2 study | Diabetic peripheral neuropathy | 5–30 mg/day | Mirogabalin was effective and well tolerated in this patient population at doses ranging from 5 to 30 mg/day in titrated doses. | (Vinik et al., 2014) |
2 | 436 | Retrospective | Diabetic peripheral neuropathy | 5–30 mg/day | Authors suggested twice daily dosing of mirogabalin instead of once daily to avoid adverse events. | (Hutmacher et al., 2016) |
3 | 32 | Open-label parallel-group study | Volunteers with varying degree of renal functions | 5 mg/day | Reduction of mirogabalin dose by 50% in subjects with moderate renal impairment and by 75% in subjects with severe renal impairment was suggested. | (Yin et al., 2016) |
4 | 452 | Phase II Proof-of-concept study | Diabetic peripheral neuropathy | 5–30 mg/day | Mirogabalin provided effective pain relief and better quality of sleep compared to placebo and 75–600 mg/day of pregabalin in a dose-dependent manner. | (Merante, 2020) |
5 | 32 | Open-label single-dose study | 16 healthy controls and 16 subjects with hepatic impairment (8 mild and 8 moderate) | 15 mg/day | A single 15-mg dose of mirogabalin was well tolerated by subjects with mild or moderate hepatic impairment. | (Duchin et al., 2018) |
6 | 53 | Randomized, placebo-controlled, double-blind study | Volunteers | 10–40 mg/day | Mirogabalin had an acceptable safety and tolerability profile in Asian and white subjects at doses up to 15 mg twice a day for 7 days. | (Jansen et al., 2018b) |
7 | 30 | Multicenter open-label study | Volunteers | 5 mg/day | Administration of a single oral 5-mg mirogabalin tablet was well tolerated in Japanese subjects with normal renal function and those with mild to severe renal impairment. | (Kato et al., 2018) |
8 | 48/47/30 | Three phase 1 pharmacokinetic (PK)/pharmacodynamics (PD) studies | Healthy volunteers | 3–75 mg/day | Mirogabalin 15 mg twice daily was selected as the highest target dose for further clinical development. | (Brown et al., 2018) |
9 | 88 | Four randomized, double-blind, placebo-controlled, 4-period drug-drug interaction studies | Healthy adults | 30 mg/day | Increased CNS adverse events when mirogabalin co-administered with lorazepam or ethanol. | (Jansen et al., 2018c) |
10 | 765 | Multicenter, double-blind, placebo-controlled phase 3 study | Post-herpetic neuralgia | 15–30 mg/day | Mirogabalin was superior to placebo in all groups for relieving PHN and appeared well tolerated. | (Kato et al., 2019) |
11 | 494 | Randomized, double-blind, placebo-controlled phase III study | Diabetic peripheral neuropathy | 15–30 mg/day | All doses (between 15 and 30 mg/day) provided significant pain relief in a dose-dependent manner compared to placebo. | (Baba et al., 2019) |
12 | 1934 | Three 13-week randomized, double-blind, placebo and active-controlled, parallel-group studies and a 52-week open-label extension study | Fibromyalgia | 15–30 mg/day | The primary endpoint of significant pain reduction in patients on mirogabalin compared with placebo was not achieved although well tolerated and showed potential for pain relief. | (Arnold et al., 2019) |
13 | 74 | Retrospective clinical investigation | Diabetic peripheral neuropathy | 10 mg/day for 1 week, 20 mg/day after 2 weeks | A significant decrease in the temporal change of VAS for lower limb pain was observed before administration and 2 and 4 weeks after administration. | (Inage et al., 2020) |
14 | 187 | Retrospective | Peripheral neuropathic pain of different etiologies | 5–10 mg/day | Mirogabalin was found safe and effective for reducing peripheral neuropathic pain. | (Tetsunaga et al., 2020) |
15 | 274 | Phase 2, double-blind, randomized, placebo-controlled study | Diabetic peripheral neuropathy | 5–10 mg/day | Mirogabalin was well tolerated in the doses with good pain relief. | (Baba et al., 2020a) |
16 | 60 | Retrospective | Lumbar spine disease | 10–30 mg/day | Mirogabalin was useful for the treatment not only of leg symptoms but also of LBP and sleep disturbance associated with lumbar spine disease. | (Kim et al., 2020) |
17 | 34 | Observational | Cancer pain | Effectiveness was 88.2% with patients having reasonable pain control. | (Nakanishi et al., 2020) | |
18 | 133 | Retrospective | Mixed | Less than 20 mg/day | Mirogabalin was effective in 85 of 133 patients. | (Kanbayashi et al., 2020) |
19 | 172 | 52-week open-label extension study | Diabetic peripheral neuropathy | 5–15 mg/day | Long-term flexible dosing of mirogabalin was safe and well tolerated. | (Baba et al., 2020b) |
20 | 35 | Phase III, open-label, 14-week study | Diabetic peripheral neuropathy or post-herpetic neuralgia | 7.5 mg once or twice daily | Mirogabalin was well tolerated and significantly reduced pain levels when used at a fixed dose of 7.5 mg once or twice daily in patients with renal impairment. | (Baba et al., 2020c) |