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

Phase 2

Recruiting

• Conditions: Chemotherapy induced peripheraly neuropathy

• Registration Number: JPRN-UMIN000041467
• Lead Sponsor: Sapporo Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-19
• Last Update Posted: 17 October 2023
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RS

Secondary Outcome Measures

Name	Time	Method
CTCAE, FACT/GOS-Nt