Crisugabalin for Radiotherapy-Related Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-07

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to evaluate whether Crisugabalin has similar efficacy compared to Pregabalin in reducing radiotherapy-related neuropathic pain (RRNP) in patients with head and neck cancers.

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Detailed Description

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The primary objective of this study is to determine whether Crisugabalin provides non-inferior pain relief compared to Pregabalin in patients with head and neck cancer experiencing radiotherapy-related neuropathic pain. The trial adopts a multicenter, randomized, open-label design, and the primary endpoint is the change in Numeric Rating Scale (NRS) pain scores from baseline to 4 weeks. The study aims to provide new evidence to support treatment strategies for this condition, which significantly affects patients' quality of life.

Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crisugabalin

The initial dose is one Crisugabalin capsule (20 mg) taken twice daily. The dose will be gradually increased to the maximum tolerated dose or the maximum daily dose of three capsules (60 mg) taken twice daily.

Group Type EXPERIMENTAL

Crisugabalin

Intervention Type DRUG

Days 1-14: Crisugabalin 40 mg/day, 20 mg twice daily, orally. Days 15-21: Increase dose to 80 mg/day, 40 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period.

Days 22-28: Increase dose to 120 mg/day, 60 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period.

Pregabalin

The initial dose is one capsule of Pregabalin (75 mg) taken twice daily. The dose will be gradually increased to the maximum tolerated dose or the maximum daily dose of four capsules (300 mg) taken twice daily.

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

Days 1-7: Pregabalin 150 mg/day, 75 mg twice daily, orally. Days 8-14: Increase dose to 300 mg/day, 150 mg twice daily. Days 15-21: Increase dose to 450 mg/day, 225 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period.

Days 22-28: Increase dose to 600 mg/day, 300 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period.

Interventions

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Crisugabalin

Days 1-14: Crisugabalin 40 mg/day, 20 mg twice daily, orally. Days 15-21: Increase dose to 80 mg/day, 40 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period.

Days 22-28: Increase dose to 120 mg/day, 60 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period.

Intervention Type DRUG

Pregabalin

Days 1-7: Pregabalin 150 mg/day, 75 mg twice daily, orally. Days 8-14: Increase dose to 300 mg/day, 150 mg twice daily. Days 15-21: Increase dose to 450 mg/day, 225 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period.

Days 22-28: Increase dose to 600 mg/day, 300 mg twice daily. If not tolerated, maintain previous dose until the end of the treatment period.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Yamei Tang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yamei Tang, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

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