Crisugabalin for Radiotherapy-Related Neuropathic Pain

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Jan 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Crisugabalin to see if it can help reduce nerve pain caused by radiotherapy in patients with head and neck cancers. The researchers want to find out if Crisugabalin works as well as another medication called Pregabalin, which is already used for this type of pain. The trial is not yet recruiting participants but aims to include adults aged 18 and older who have been diagnosed with head and neck tumors and have been treated with radiotherapy at least six months before joining the study.

To be eligible, participants should have ongoing nerve pain that has lasted for at least four weeks and is linked to the area where they had radiotherapy. They also need to be able to understand and sign a consent form. However, certain health conditions or recent treatments may exclude individuals from participating, such as severe kidney or liver problems, certain chronic diseases, or if they have used similar medications recently. Participants can expect to take the study medication and complete questionnaires about their pain and overall health during the trial. It's important to note that women who are pregnant or breastfeeding cannot participate, and all participants must use reliable contraception during the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ability to understand and voluntarily sign a written informed consent form.
• • 2. Male or female patients aged ≥18 years with an expected survival of at least 5 months.
• • 3. Histologically confirmed head and neck tumors treated with radiotherapy at least 6 months prior to screening.
• • 4. Average NRS pain score ≥4 over 7 days during the screening period, with pain localized to nerve-innervated areas corresponding to the radiotherapy site, such as the head, face, neck, and arms.
• • 5. Diagnosis of neuropathic pain persisting for at least 4 weeks, confirmed by two trained neurologists based on clinical history, symptoms, signs, and a Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score ≥12 (Chinese version).
• • 6. Adequate cognitive and language abilities to communicate and complete study questionnaires.
• Exclusion Criteria:
• 1. Severe abnormalities in hematological, hepatic, or renal function, as evidenced by:
• • Hematology: Neutrophil count \<1.5×10⁹/L, platelet count \<90×10⁹/L, or hemoglobin \<100 g/L.
• • Liver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× upper limit of normal (ULN), or total bilirubin (TBIL) \>1.5× ULN.
• • Renal function: Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² or undergoing dialysis.
• • Creatine kinase \>2× ULN.
• 2. Chronic systemic diseases that may interfere with study participation, including but not limited to:
• • Severe cardiopulmonary diseases such as unstable angina, myocardial infarction, severe arrhythmia, WHO functional classification III-IV heart failure, uncontrolled hypertension (systolic BP \>160 mmHg or diastolic BP \>100 mmHg), or recurrent asthma.
• • Chronic gastrointestinal diseases, such as liver fibrosis, recurrent indigestion or diarrhea, or peptic ulcers.
• • Neurological or psychiatric conditions affecting pain assessment, including epilepsy, recurrent dizziness, headache, memory, or cognitive disorders; cerebrovascular accidents or transient ischemic attacks within 6 months of screening.
• • 3. Known allergy to study drugs or chemically related compounds.
• • 4. Current diagnosis of tumor recurrence or metastasis associated with tumor-related pain.
• • 5. Neuropathic pain not caused by radiotherapy, such as postherpetic neuralgia, diabetic neuropathy, HIV-related neuropathy, spinal cord injury, or other neurological diseases.
• • 6. Use of pregabalin/crisugabalin within 4 weeks before screening.
• • 7. Pregnant, planning to become pregnant during the study, or breastfeeding. Participants and their partners unwilling to use reliable contraception (e.g., condoms, spermicides, intrauterine devices) from the time of consent until 28 days after the last dose of study medication.
• • 8. Participation in any other clinical trial within 30 days prior to screening.
• • 9. Any other condition deemed unsuitable for study participation by the investigator.
• • 10. Use of prohibited medications within at least 5 half-lives of the drug before screening, with prohibition maintained throughout the study.
• • 11. Previous use of pregabalin ≥300 mg/day or gabapentin ≥1200 mg/day deemed ineffective.