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Crisugabalin for treating neuropathic pain after radiotherapy in head and neck cancer patients

Crisugabalin Versus Pregabalin for Radiotherapy-Related Neuropathic Pain in Head and Neck Cancers: A Multicenter, Randomized, Open-Label, Non-Inferiority Trial

Phase 2 Interventional Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT06766916

This study is testing if Crisugabalin can help reduce nerve pain after radiation treatment in people with head and neck cancer better than Pregabalin.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment172 (estimated)
Ages18 Years and up
SexAll
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other
Locations11 sites (Fuzhou, Fujian and 10 other locations)
Trial IDNCT06766916 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of Crisugabalin compared to Pregabalin in alleviating radiotherapy-related neuropathic pain in patients with head and neck cancers. It employs a multicenter, randomized, open-label design, focusing on the change in Numeric Rating Scale (NRS) pain scores over a 4-week period. The goal is to provide new evidence that could enhance treatment strategies for patients suffering from this debilitating condition, which significantly impacts their quality of life.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed head and neck tumors who have experienced neuropathic pain for at least 4 weeks following radiotherapy.

Not a fit: Patients with severe abnormalities in hematological, hepatic, or renal function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer an effective alternative treatment for neuropathic pain in patients recovering from head and neck cancer.

How similar studies have performed: Previous studies have shown promising results with similar approaches in managing neuropathic pain, but this specific comparison of Crisugabalin and Pregabalin is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Fuzhou, Fujian and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neuropathic PainHead and Neck CancersRadiotherapy-Related Neuropathic PainCrisugabalin
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.