occipital neuralgia
Conditions
Interventions
Crisugabalin Besilate Capsules Treatment Group:None
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Meet the diagnostic criteria for occipital neuralgia according to the Third Edition of the International Classification of Headache Disorders (ICHD-3) published in 2018; 3. First-time use of Crisugabalin Besilate Capsules; 4. Have an average pain Numerical Rating Scale (NRS) score of >= 4 points in the past 24 hours at the time of screening; 5. Be capable of understanding the procedures and methods of this trial, be willing to strictly comply with the clinical study protocol to complete the trial, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with traumatic brain injury or intracranial lesions; 2. Exclusion of headache attributed to cerebrovascular disease, central nervous system infection, or systemic disease; medication-overuse headache; new daily persistent headache; and migraine; 3. Presence of chronic systemic diseases that, in the investigator’s assessment, may affect the subject’s participation in the study, including but not limited to: (1) severe cardiopulmonary diseases, such as unstable angina, myocardial infarction, severe arrhythmia; New York Heart Association (NYHA) functional class III–IV at screening; hypertension poorly controlled despite active treatment, with systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening; recurrent asthma attacks, etc.; (2) neuropsychiatric disorders that, in the investigator’s opinion, may affect pain evaluation or self-assessment, including epilepsy, recurrent dizziness, headache, memory and cognitive impairment; cerebrovascular accident or transient ischemic attack within 6 months prior to screening; 4. Severe hepatic or renal impairment, meeting any of the following clinical laboratory findings: (1) hepatic function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN); or total bilirubin (TBIL) > 1.5 × ULN; (2) estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2 (calculated using the simplified MDRD formula).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale (NRS) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD) Score;Daily Sleep Interference Scale (DSIS);Hamilton Anxiety Rating Scale (HAMA) Score;Short-Form McGill Pain Questionnaire (SF-MPQ); | — |
Countries
China
Contacts
Public ContactShuqin Zhan
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed