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The Study Regarding Influence on Safety and Efficacy of
Switching from Pregabalin to Mirogabalin in Patients with
Peripheral Neuropathic Pain

MIROP Study

152

A similar proportion of male (79 patients, 52.0%) and female (73 patients, 48.0%) patients were enrolled, with a mean +- SD age of 66.1 +- 12.9 years and a mean +- SD VAS score of 67.4 +- 16.9 mm at enrollment. Mean +- SD CrCL at enrollment was 82.51 +- 37.44 mL/min. Mean +- SD pregabalin daily dose in patients overall was 122.7 +- 75.1 mg/day at informed consent, and 102.0 +- 44.7 mg/day at enrollment.

Informed consent was obtained from 157 patients; of these, 152 patients met the eligibility criteria, were enrolled in the study, and were included in the safety analysis set. The efficacy analysis set consisted of 151 patients. One patient was excluded because no VAS measurement was available after administration of mirogabalin. A total of 136 patients completed the study and 16 patients discontinued the study. The most common reason for discontinuation was AEs (10 patients).

59.2% (90 patients) experienced at least one AE and 54.6% (83 patients) experienced at least one adverse drug reaction during study period. Two serious AEs not leading to discontinuation (lymphoma and cerebrovascular accident) were reported and a causal relationship between mirogabalin and the serious AEs was ruled out. 13.8% (21 patients) discontinued treatment due to an AE, of which 13 patients and 8 patients discontinued during and after the study period, respectively. All AEs leading to treatment discontinuation were considered to be related to mirogabalin. No death were reported.

The primary endpoints were the incidences of somnolence, dizziness, and peripheral edema from enrollment to the end of the study. During the study period, the overall incidences (patients) of somnolence, dizziness, and peripheral edema were 41.4% (63 patients) 15.8% (24 patients), 2.6% (4 patients), respectively. Most cases were mild (somnolence 31.6% (48 patients), dizziness 15.1% (23 patients), peripheral edema 2.0% (3 patients)). Overall, 9.9% (15 patients) of somnolence and 0.7% (1 patient) of peripheral edema were moderate, and there was 0.7% (1 patient) of severe dizziness. The secondary endpoints were changes in pain intensity (VAS score) from enrollment (Day 1) to the end of the study (Day 29) and the time of visit during the study (Day 15). Mean VAS score decreased from Day 1 (67.4 +- 16.9 mm) to Day 15 (54.3 +- 22.8 mm) and Day 29 (51.9 +- 25.4 mm). Mean changes from Day 1 to Day 15 and Day 29 were -13.2 +-19.4 mm and -15.7 +- 24.1 mm, respectively (both p<0.0001).

Mirogabalin switching from pregabalin is generally well tolerated and effective in pain management for peripheral neuropathic pain.

June. 30, 2021

April. 15, 2021

https://link.springer.com/article/10.1007/s40122-021-00255-y

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs031190113

Kimura Yoshiyuki

Dokkyo Medical Universitiy

880 Kitakobayashi, Shimotsuga-gun Tochigi 321-0293, JAPAN

y-kimura@dokkyomed.ac.jp

Yabe Hiroshi

EP-CRSU CO., LTD

3F Acropolis TOKYO, 6-29 Shinogawamachi, Shinjuku-ku, Tokyo, Japan

+81-3-5946-9904

yabe684@eps.co.jp

Complete

Oct. 15, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Patients diagnosed with Peripheral Neuropathic Pain.
2) Patients who is administrated Pregabalin for more than 28 days at enrollment of the study.
3) Patients with more than 40mm of VAS at informed consent and enrollment.
4)Patients with 20 years old or older at enrollment.
5)Patients who give their voluntary Written consent to participate in the study, also patients who are able to understand the procedure of the clinical study and answer a question appropriately.

1) Patients who have past history of hypersensitivity to ingredients of Mirogabalin and Pregabalin.
2) Patients who have difficuly participating in the study due to severe complication of Liver Disease, Kidney Disease and Heart Disease.
3) Patients with creatinine clearance less than 30mL/min by Cockroft-Gault Equation at enrollment.
4) Pregnancy patients or patients who have possibility of pregnancy.
5) Nursing mothers.
6) Patients who are inappropriate for participation in the study for other reason in the opinion of the investigator or sub-investigator.

Both

Peripheral Neuropathic Pain

The alternative drug of Pregabalin approved to control pain is limited to Mirogabalin. And administration of Pregabalin is finished at enrollment.
At the time, regimen of Mirogabalin is as written below in accordance with the package insert when.
Target patients with creatinine clearance more than 60mL/min: If Pregabalin more than 150mg/day is administrated at informed consent, Pregabalin is decreased to less than 150mg/day gradually over the course of one week. After enrollment, Mirogabalin is administrated in dose of 5mg twice a day at the first week. At the next week, Mirogabalin is administrated in dose of 10mg twice a day. At the next following two weeks, dose of Mirogabalin is increased to 15mg twice a day unless there is no problem with the tolerance.
Target patients with creatinine clearance 30-60mL/min: If Pregabalin more than 75mg/day is administrated at informed consent, Pregabalin is decreased to less than 75mg/day gradually over the course of one week. After the enrollment, Mirogabalin is administrated in dose of 2.5mg twice a day at the first week. At the next week, Mirogabalin is administrated in dose of 5mg twice a day. At the next following two weeks, dose of Mirogabalin is increased to 7.5mg twice day unless there is no problem with the tolerance.
However if Mirogabalin is administrated to the patient with Kidney Disease, the increase of dose is considered if the patient has a tolerance and does not respond to the present treatment.

Rate of occurrence of Somnolence, Dizziness and Peripheral edema from the enrollment to the end of the study

Amount of the change of pain intensity(VAS) from the enrollment to the end of the study

+81-3-3972-8111

Sept. 11, 2019

None