Neuropathic Pain in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)
Conditions
Interventions
Crisugabalin group:Crisugabalin
Placebo group:Placebo+Crisugabalin
Sponsors
The Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be enrolled in this study: 1. Able to understand and voluntarily sign the written informed consent form; 2. Male or female aged between 18 years (inclusive) and 75 years; 3. Diagnosed with neuromyelitis optica spectrum disorder (NMOSD) according to the International Panel for NMO Diagnosis (IPND, 2015) criteria; 4. Patients with comorbid neuropathic pain, DN4 >= 4; no change in medication dosage within the past month; 5. Numeric Rating Scale (NRS) for pain score >= 4 at screening; 6. First-time use of Crisugabalin Capsules.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be enrolled in this study: 1. Presence of peripheral neuropathy or pain unrelated to NMOSD that, in the investigator's judgment, may confound the assessment; 2. Known history of allergy to the investigational drug components, or to other drugs with similar chemical structures, or to any excipients; 3. Prior use of pregabalin >= 300 mg/day, gabapentin >= 1200 mg/day, or mirogabalin >= 30 mg/day with lack of clinical efficacy as judged by the investigator; 4. Severe liver or kidney function abnormalities (ALT or AST > 2 × upper limit of normal, creatinine clearance < 60 mL/min); 5. Women who are pregnant, planning to become pregnant during the study period, or currently breastfeeding; subjects who are unwilling to use reliable contraceptive measures (including condoms, spermicides, intrauterine devices, etc.) from the time of signing the ICF until 28 days after the last dose of the investigational drug. 6. Participated in any other clinical study within 30 days prior to screening 7. The researcher determines that there are other situations in which participation in the study is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS response rate;SF-MPQ score;DSIS score;PSFS score;HAMA score;HAMD score; | — |
Countries
China
Contacts
Public ContactJun Guo
The Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army of China(Tangdu Hospital, Air Force Medical University)
Outcome results
None listed