Crisugabalin for Radiotherapy-Related Neuropathic Pain (CRYSTAL)

May 14, 2025 updated by: Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jingfeng Zong
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • Haiqiang Mai
        • Contact:
        • Sub-Investigator:
          • Liting Liu
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Principal Investigator:
          • Yamei Tang
        • Contact:
        • Sub-Investigator:
          • Songhua Xiao
      • Guangzhou, Guangdong, China, 510095
        • Not yet recruiting
        • Affillated Cancer Hospital and Institute of Guangzhou Medical University
        • Contact:
        • Sub-Investigator:
          • Bin Qi
        • Principal Investigator:
          • Dongping Chen
      • Guangzhou, Guangdong, China, 510370
        • Not yet recruiting
        • The Affiliated Brain Hospital, Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • Dong Zheng
      • Zhongshan, Guangdong, China, 528403
        • Not yet recruiting
        • Zhongshan People's Hospital
        • Contact:
        • Principal Investigator:
          • Kui Lu
    • Guangxi
      • Nanning, Guangxi, China, 510120
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
        • Principal Investigator:
          • Yuan Wu
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital (Affiliated Cancer Hospital of ZhengzhouUniversity)
        • Contact:
        • Principal Investigator:
          • Guanglun Xie
    • Hunan
      • Changsha, Hunan, China, 410005
        • Not yet recruiting
        • Hunan Provincial People's Hospital
        • Principal Investigator:
          • Huaxin Duan
        • Contact:
      • Changsha, Hunan, China, 410007
        • Not yet recruiting
        • Hunan Brain Hospital
        • Principal Investigator:
          • Nong Yang
        • Contact:
      • Changsha, Hunan, China, 41004
        • Not yet recruiting
        • Changsha Central Hospital
        • Principal Investigator:
          • Guihua Wang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) Change
Time Frame: 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) Change
Time Frame: 4 weeks
The VAS measures pain intensity on a 0-100 mm scale, with 0 representing no pain and 100 representing the worst imaginable pain.
4 weeks
Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) scores
Time Frame: 4 weeks
The HAMA and HAMD are used to evaluate anxiety and depressive symptoms, respectively.
4 weeks
Daily Sleep Interference Scale (DSIS)
Time Frame: 4 weeks
The DSIS measures the impact of pain on sleep quality. Scores range from 0 (no interference) to 10 (complete interference).
4 weeks
Response Rates
Time Frame: 4 weeks
The proportion of patients achieving ≥30% and ≥50% reductions in NRS score from baseline to Week 4.
4 weeks
Short-Form McGill Pain Questionnaire (SF-MPQ)
Time Frame: 4 weeks

Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score:

Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe); Part 2 - the VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain; Part 3 - a present pain intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain).
4 weeks
Numeric Rating Scale (NRS) Change
Time Frame: 1 week
The change in NRS score from baseline to Week 1 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.
1 week
Health Status According to EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L)
Time Frame: 4 weeks

The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension.

The health state index value is a single value on a scale from 0 to 100 scores indicating better health: 0 = indicating worst health and 100 = best imaginable health.
4 weeks
Patient Global Impression of Change (PGIC)
Time Frame: 4 weeks
PGIC is a 7 point scale depicting a patient's rating of overall improvement, with 1 representing very much improved and 7 representing very much worse.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Yamei Tang, M.D., PhD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 5, 2025

First Submitted That Met QC Criteria

January 5, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2024-1020-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will be available from Principal Investigator upon reasonable request 6 months after the trial completion.

IPD Sharing Time Frame

6 months after the trial completion

IPD Sharing Access Criteria

The IPD will be available from Principal Investigator upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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