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Effect of Mirogabalin in patients with Chemotherapy-induced peripheral neuropathy : A Multicenter, Phase 2 Trial

Effect of Mirogabalin in patients with Chemotherapy-induced peripheral neuropathy : A Multicenter, Phase 2 Trial - M-CIPN

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041467
Enrollment
100
Registered
2020-08-19
Start date
2020-04-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy induced peripheraly neuropathy

Interventions

We prescribe mirogabalin for up to 12 weeks.

Sponsors

Sapporo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with pathologically consistent with multiple myeloma, malignant lymphoma, gastric cancer, colorectal cancer, sarcoma or pancreatic cancer. 2. Patiesnts with administered Bordezomib, vincristine, platinum preparations (cisplatin, oxaliplatin), or microtubule inhibitor preparations (paclitaxel, paclitaxel, Nabupaclitaxel, docetaxel, eribulin). 3. CTCTE ver5.0 Grade 2 or more, NRS 4 points to NRS 8 points/10 points CIPN. 4. over 20 years old. 5. Informed consent had been obtained.

Exclusion criteria

Exclusion criteria: 1. Other than multiple myeloma, malignant lymphoma, gastric cancer, colon cancer, sarcoma and pancreatic cancer. 2. CIPN of Grade 1 or lower, or NRS 3 points or lower or NRS 9 points or higher in CTCTE ver5.0. 3. CIPN thought to be caused by other than bordezomib, vincristine, platinum preparations (cisplatin, oxaliplatin), and microtubule inhibitor preparations (paclitaxel, nabupaclitaxel, docetaxel, eribulin). 4. ECOG-PS4 or poor general condition. 5. Patients who are using the following drugs in combination: antidepressants, SSRI/SNRI, antiepileptic drugs, opioids, goshajinkigan, Vitamin B12 preparations. 6. Diagnosed as severe heart disease or lung disease. 7. Diagnosed as poor renal function with creatinine clearance of less than 60 mL/min. 8. Pregnant women, lactating women or those who may be pregnant. 9. The patients who were ineligible.

Design outcomes

Primary

MeasureTime frame
NRS

Secondary

MeasureTime frame
CTCAE, FACT/GOS-Nt

Countries

Japan

Contacts

Public ContactMAKOTO YOSHIDA

Sapporo Medical University Department of Medical Oncology

yoshimako10@sapmed.ac.jp011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026