BridgeMD
New treatment option for Neuropathic Pain
Official title Crisugabalin for Radiotherapy-Related Neuropathic Pain
ClinicalTrials.gov ID: NCT06766916
What this study is testing
What is Crisugabalin?
Crisugabalin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for neuropathic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Diagnosis of neuropathic pain persisting for at least 4 weeks, confirmed by two trained neurologists based on clinical history, symptoms, signs, and...
You likely can't join 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×...
- 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:
See the full eligibility criteria
- 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...
- Adequate cognitive and language abilities to communicate and complete study questionnaires.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Zhongshan, Guangdong, China
- Nanning, Guangxi, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Zhongshan, Guangdong, China; Nanning, Guangxi, China; Zhengzhou, Henan, China; Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.