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Study of Mirogabalin and pregabalin to Improve Limb nEuropathy

Study of Mirogabalin and pregabalin to Improve Limb nEuropathy - SMILE-CIPN

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1071250142
Enrollment
48
Registered
2026-03-16
Start date
2026-03-16
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

Breast cancer Breast neoplasm, Chemotherapy, Peripheral Neuropathies

Interventions

Pregabalin or mirogabalin will be administered as therapeutic agents for peripheral neuropathy.
D000068654, D000074570
Pregabalin, Mirogabalin

Sponsors

Kuba Sayaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients who have received perioperative chemotherapy for breast cancer and have developed chemotherapy-induced peripheral neuropathy (CIPN). 2) Patients who are able to complete a patient diary and questionnaire survey. 3) Patients aged between 18 and 80 years at the time of obtaining informed consent. 4) Patients who have provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Patients who have peripheral neuropathy prior to the initiation of chemotherapy. 2) Patients who are currently taking pregabalin or mirogabalin besilate. 3) Patients who are pregnant or breastfeeding. 4) Patients who are currently participating in another clinical trial or clinical study. 5) Patients whom the principal investigator or subinvestigator deems inappropriate for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
NRS (Numerical Rating Scale)

Secondary

MeasureTime frame
CTCAE ver6.0, PRO-CTCAE

Contacts

Public ContactSayaka Kuba

Nagasaki University Hospital

skuba@nagasaki-u.ac.jp+81-958197316

Outcome results

None listed

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