Crisugabalin for Radiotherapy-Related Neuropathic Pain

NCT06766916 | Recruiting Phase 2

• 1 other identifier: SYSKY-2024-1020-02
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Neuropathic Pain

Keywords

Head and Neck Cancers; Radiotherapy-Related Neuropathic Pain; Crisugabalin

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS) Change

  The change in NRS score from baseline to Week 4 of treatment. The NRS measures pain intensity on a scale of 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

  4 weeks

Secondary Outcomes (8)

• Numeric Rating Scale (NRS) Change

  1 week

• Visual Analogue Scale (VAS) Change

  4 weeks

• Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) scores

  4 weeks

• Daily Sleep Interference Scale (DSIS)

  4 weeks

• Health Status According to EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L)

  4 weeks

Study Arms (2)

Crisugabalin

EXPERIMENTAL

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.

Drug: Crisugabalin

Pregabalin

ACTIVE COMPARATOR

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.

Drug: Pregabalin

Interventions

Crisugabalin 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.

Crisugabalin

Pregabalin 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.

Pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and voluntarily sign a written informed consent form.
• Male or female patients aged ≥18 years with an expected survival of at least 5 months.
• Histologically confirmed head and neck tumors treated with radiotherapy at least 6 months prior to screening.
• 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.
• 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).
• Adequate cognitive and language abilities to communicate and complete study questionnaires.

You may not qualify if:

• 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.
• 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.
• Known allergy to study drugs or chemically related compounds.
• Current diagnosis of tumor recurrence or metastasis associated with tumor-related pain.
• Neuropathic pain not caused by radiotherapy, such as postherpetic neuralgia, diabetic neuropathy, HIV-related neuropathy, spinal cord injury, or other neurological diseases.
• Use of pregabalin/crisugabalin within 4 weeks before screening.
• 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.
• Participation in any other clinical trial within 30 days prior to screening.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (11)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Affillated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

NOT YET RECRUITING

The Affiliated Brain Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510370, China

NOT YET RECRUITING

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 510120, China

NOT YET RECRUITING

Henan Cancer Hospital (Affiliated Cancer Hospital of ZhengzhouUniversity)

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, 410005, China

NOT YET RECRUITING

Hunan Brain Hospital

Changsha, Hunan, 410007, China

NOT YET RECRUITING

Changsha Central Hospital

Changsha, Hunan, 41004, China

NOT YET RECRUITING

MeSH Terms

Conditions

Neuralgia; Head and Neck Neoplasms

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yamei Tang, M.D., PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Songhua Xiao

CONTACT

86+13922232774; xiaosh@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: May 7, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after the trial completion
• Access Criteria: The IPD will be available from Principal Investigator upon reasonable request.

Locations

CN (11)