A Multicenter, Observational Study of Crisugabalin in the Real-World Treatment of Patients with Paresthesia Caused by Diabetic Distal Symmetric Polyneuropathy

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600117229

Enrollment

Unknown

Registered

2026-01-21

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Paresthesia Caused by Diabetic Distal Symmetric Polyneuropathy

Interventions

Crisugabalin:N/A

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. The patient has been diagnosed with Distal Symmetric Polyneuropathy (DSPN); 3. At the time of visit, the Toronto Clinical Neuropathy Score (TCNS) is >=6 points, and the pain Numeric Rating Scale (NRS) score is <4 points; 4. The treatment plan includes first-time use or planned use of Crisugabalin Besilate Capsules; 5. The patient and their family members are fully informed about this study and voluntarily agree to participate.

Exclusion criteria

Exclusion criteria: 1. Participation in any other clinical study within 30 days prior to screening. 2. Any other condition deemed by the investigator as unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
Changes in the modified Toronto Clinical Neuropathy Score (mTCNS) from baseline after 4 weeks of treatment;	—

Secondary

Measure	Time frame
Toronto Clinical Neuropathy Score;Sleep Disturbance Score;Patients Global Impression of Change;	—

Countries

China

Contacts

Public ContactHua Wei

Guangdong Provincial Hospital of Traditional Chinese Medicine

13829701168@163.com+86 138 2970 1168

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026