Chemotherapy-Induced Neuropathic Pain
Conditions
Interventions
Crisugabalin group:Take 2 Cyrgablin capsules orally twice a day. If not tolerated due to safety, the dose can be adjusted to 20 mg BID.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older (including 18 years old), regardless of gender; 2.Tumor patients who are currently receiving chemotherapy and have developed chemotherapy-induced neuropathic pain (CIPN) symptoms, or tumor patients who have received chemotherapy in the past and still have neuropathic pain symptoms; 3.Chemotherapy-induced neuropathic pain (CIPN) grade >= 2 at screening; 4.Having neuropathic pain symptoms of CIPN, with a score of >= 4 on the Douleur Neuropathique 4 Questions (DN4) questionnaire; 5.The average numerical rating scale (NRS) score for pain in the past 24 hours is >=4 at screening; 6.Able to understand the procedures and methods of this trial, willing to strictly abide by the clinical research protocol to complete the trial, and voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed by a doctor with peripheral neuropathy or pain unrelated to chemotherapy-induced peripheral neuropathy (CIPN); (including but not limited to those caused by cerebrovascular diseases, cervical and lumbar spine diseases, osteoarticular or tendinous lesions, chronic kidney disease or uremia, thyroid diseases, intracranial tumors, trauma, etc.), which may interfere with the assessment of CIPN; 2.Presence of conditions that the researcher deems may affect pain assessment, such as skin diseases in the affected skin area that may impact sensation; 3.Having chronic systemic diseases that the researcher assesses may affect the subject's participation in the study, including but not limited to: (1) Suffering from severe cardiopulmonary diseases, such as unstable angina pectoris, myocardial infarction, severe arrhythmia, World Health Organization (WHO) cardiac function classification of Grade III–IV at screening, poorly controlled hypertension despite active treatment (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening); recurrent asthma attacks, etc.; (2) Suffering from chronic digestive system diseases, such as liver diseases like liver fibrosis, recurrent dyspepsia or diarrhea, etc.; (3) Presence of neuropsychiatric system diseases that the researcher deems may affect the evaluation of CIPN or self-rating, including epilepsy, recurrent dizziness, headache, memory and cognitive impairment; cerebrovascular accident or transient ischemic attack within 6 months before screening, etc.; 4.Severe hematological, hepatic, or renal dysfunction, meeting any of the following clinical laboratory test results:(1) Hematology: Neutrophils 2.5×upper limit of normal (ULN); or total bilirubin (TBIL) > 1.5×ULN;(3) Estimated glomerular filtration rate (eGFR) 2.0×ULN. Known history of substance abuse and/or alcoholism: Weekly alcohol consumption exceeding 14 standard drinks (1 standard drink is equivalent to 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine). 5.Subjects with any active infection at screening that the investigator deems inappropriate for inclusion. 6.Subjects who used prohibited drugs before screening, or changed restricted concomitant medications within 30 days before screening; if a subject used a prohibited drug before screening, they must discontinue the drug for at least 5 half-lives (specific half-life is based on the drug instruction manual) before the screening visit to be eligible for screening, and must discontinue the drug throughout the entire study period. 7.Previous use of pregabalin at a dose of >= 300 mg/day or gabapentin at a dose of >=1200 mg/day, with a reported lack of clinical efficacy. 8.Known history of allergy to the components of the study drug, other drugs with similar chemical structures, or excipients. 9.Subjects with a history of suicidal behavior or suicidal ideation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Grade Relative to Baseline;Changes in EuroQol Five-Dimension Health Scale, Five-Level Version (EQ-5D-5L) Score of Participants Relative to Baseline After 4 Weeks of Treatment;Incidence of Adverse Events and Serious Adverse Events Within 4 Weeks of Monotherapy with Oral Crisugabalin Besilate Capsules;Changes in Average Daily Sleep Interference Score (ADSIS) Relative to Baseline;Changes in Patient Global Impression of Change (PGIC) Score Relative to Baseline After 4 Weeks of Treatment; | — |
Countries
China
Contacts
Public ContactJingDun Xie
Sun Yat-sen University Cancer Center
Outcome results
None listed