Fibromyalgia
Conditions
Interventions
pregabalin group:pregabalin
crisogabalin group:crisogabalin
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males or females aged 18 or above; 2. Clear history of FM, meeting the 2016 ACR diagnostic criteria for FM; 3. The average Visual Analog Scale (VAS) score of >= 40mm in the past 24 hours during screening.
Exclusion criteria
Exclusion criteria: 1. Participated in any other clinical studies within the 30 days prior to screening; 2. Liver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>2.5 times the upper limit of normal (ULN); Or total bilirubin (TBIL)>1.5 × ULN; 3. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m^2; 4. Subject treated with Crisogabalin, Mirogabalin, Pregabalin, or Gabapentin within 28 days prior to screening, ; otherwise, a 28 day washout period is required; 5. Women who are pregnant, preparing for pregnancy or breastfeeding during the study period; 6. Patients allergic to experimental drugs or excipients; 7. Other circumstances that that the investigator determines that there are are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily Sleep Interference Scale, DSIS;short form McGill pain questionnaire; | — |
Countries
China
Contacts
Public ContactWujun Geng
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed