Actively Recruiting
Crisugabalin for Radiotherapy-Related Neuropathic Pain
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-05-18
172
Participants Needed
11
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Crisugabalin for Radiotherapy-Related Neuropathic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent.
- Male or female aged 18 years or older with expected survival of at least 5 months.
- Histologically confirmed head and neck tumors treated with radiotherapy at least 6 months before screening.
- Average Numeric Rating Scale pain score of 4 or higher over 7 days during screening.
- Neuropathic pain lasting at least 4 weeks, confirmed by two neurologists and a LANSS score of 12 or more.
- Sufficient cognitive and language skills to communicate and complete questionnaires.
You will not qualify if you...
- Severe blood, liver, or kidney abnormalities (e.g., low neutrophil or platelet counts, high liver enzymes, low kidney function).
- Chronic diseases that may affect participation, including severe heart or lung conditions, uncontrolled high blood pressure, recurrent asthma, liver fibrosis, digestive disorders, or peptic ulcers.
- Neurological or psychiatric disorders impacting pain evaluation, such as epilepsy, memory problems, or recent stroke.
- Allergy to study drugs or related compounds.
- Current tumor recurrence or metastasis causing pain.
- Neuropathic pain not caused by radiotherapy.
- Use of pregabalin or crisugabalin within 4 weeks before screening.
- Pregnancy, breastfeeding, or unwillingness to use contraception during the study.
- Participation in other clinical trials within 30 days before screening.
- Any condition that the investigator considers unsuitable.
- Use of prohibited medications within at least 5 drug half-lives before screening.
- Previous ineffective treatment with high doses of pregabalin or gabapentin.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
2
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
4
Affillated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
Not Yet Recruiting
5
The Affiliated Brain Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China, 510370
Not Yet Recruiting
6
Zhongshan People's Hospital
Zhongshan, Guangdong, China, 528403
Not Yet Recruiting
7
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 510120
Not Yet Recruiting
8
Henan Cancer Hospital (Affiliated Cancer Hospital of ZhengzhouUniversity)
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
9
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
Not Yet Recruiting
10
Hunan Brain Hospital
Changsha, Hunan, China, 410007
Not Yet Recruiting
11
Changsha Central Hospital
Changsha, Hunan, China, 41004
Not Yet Recruiting
Research Team
S
Songhua Xiao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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