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Neuropathic PainPhase 2CRYSTALNCT06766916

Crisugabalin for Radiotherapy-Related Neuropathic Pain

A Phase 2 study testing Crisugabalin and Pregabalin in people with Neuropathic Pain, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 11 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuropathic Pain
What is being tested?
Crisugabalin and Pregabalin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
11 sitesChina
Study dates
7 May 2025to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 18Show fewer
  • 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.
  • Any other condition deemed unsuitable for study participation by the investigator.
  • Use of prohibited medications within at least 5 half-lives of the drug before screening, with prohibition maintained throughout the study.
  • Previous use of pregabalin ≥300 mg/day or gabapentin ≥1200 mg/day deemed ineffective.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Songhua Xiao contact

86+13922232774

xiaosh@mail.sysu.edu.cn

11 sites in 1 country

China11 sites, 11 recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

    Huaxin Duan, 86+13347315509, 317102912@qq.com

    Huaxin Duan

    Not yet recruiting

  • Hunan Brain Hospital

    Changsha, Hunan, 410007

    Nong Yang, 86+13055193557, 13055193557@qq.com

    Nong Yang

    Not yet recruiting

  • Changsha Central Hospital

    Changsha, Hunan, 41004

    Guihua Wang, 86+18874186878, 18874186878@qq.com

    Guihua Wang

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Jingfeng Zong, 86+13365910013, zongjingfeng@126.com

    Jingfeng Zong

    Not yet recruiting

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

    Guangzhou, Guangdong, 510000

    Songhua Xiao, 86+13922232774, xiaosh@mail.sysu.edu.cn

    Songhua Xiao

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Haiqiang Mai, 86+135 7002 7338, maihq@sysucc.org.cn

    Haiqiang Mai

    Not yet recruiting

  • Affillated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510095

    Dongping Chen, 86+13302215492, chen_dpgz@163.com

    Bin Qi

    Not yet recruiting

  • The Affiliated Brain Hospital, Guangzhou Medical University

    Guangzhou, Guangdong, 510370

    Dong Zheng, 86+13632333988, 2019760137@gzhmu.edu.cn

    Dong Zheng

    Not yet recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 510120

    Yuan Wu, 86+136 0771 3316, wuyuan90@126.com

    Yuan Wu

    Not yet recruiting

  • Henan Cancer Hospital (Affiliated Cancer Hospital of ZhengzhouUniversity)

    Zhengzhou, Henan, 450003

    Guanglun Xie, 86+139 3902 9792, xieguanglun@126.com

    Guanglun Xie

    Not yet recruiting

  • Zhongshan People's Hospital

    Zhongshan, Guangdong, 528403

    Kui Lu, 86+18028389017, lukui945@163.com

    Kui Lu

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Crisugabalin, Pregabalin
Keywords
Head and Neck Cancers, Radiotherapy-Related Neuropathic Pain, Crisugabalin
Medical subject headings
Neuralgia, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CrisugabalinDrug

    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.

  • PregabalinDrug

    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.

Study groups in NCT06766916
Study groupRoleWhat they receive
CrisugabalinExperimentalThe 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.
Receives: Drug: Crisugabalin
PregabalinActive comparatorThe 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.
Receives: Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (8)

  1. Numeric Rating Scale (NRS) Change

    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.

    Measured: 1 week

  2. Visual Analogue Scale (VAS) Change

    The VAS measures pain intensity on a 0-100 mm scale, with 0 representing no pain and 100 representing the worst imaginable pain.

    Measured: 4 weeks

  3. Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) scores

    The HAMA and HAMD are used to evaluate anxiety and depressive symptoms, respectively.

    Measured: 4 weeks

  4. Daily Sleep Interference Scale (DSIS)

    The DSIS measures the impact of pain on sleep quality. Scores range from 0 (no interference) to 10 (complete interference).

    Measured: 4 weeks

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

    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.

    Measured: 4 weeks

  6. Response Rates

    The proportion of patients achieving ≥30% and ≥50% reductions in NRS score from baseline to Week 4.

    Measured: 4 weeks

  7. Short-Form McGill Pain Questionnaire (SF-MPQ)

    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).

    Measured: 4 weeks

  8. Patient Global Impression of Change (PGIC)

    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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start7 May 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06766916
Sponsor's protocol ID
SYSKY-2024-1020-02
Acronym
CRYSTAL
Status last verified
Feb 2025
First submitted
5 Jan 2025
Last updated
18 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The IPD will be available from Principal Investigator upon reasonable request 6 months after the trial completion.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Crisugabalin and Pregabalin in people with Neuropathic Pain, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Songhua Xiao (86+13922232774, xiaosh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Rating Scale (NRS) Change (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06766916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.

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