Actively Recruiting
Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
Led by Peking University Third Hospital · Updated on 2023-11-22
64
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral sclerosis (ALS) patients.
CONDITIONS
Official Title
Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of probable, clinically probable, or definite sporadic or familial amyotrophic lateral sclerosis (ALS) based on World Federation of Neurology modified El Ecorial criteria with laboratory support
- Age between 18 and 80 years old
- ALS duration no longer than 18 months from symptom onset
- ALS Functional Rating Scale-Revised (ALSFRS-R) total score 27 or higher, with each item scored at least 2 (dyspnoea, orthopnea, and respiratory insufficiency score at least 3)
- Forced vital capacity (FVC) at least 70% of predicted normal for gender, height, and age
- Brain function AI analysis consistent with depressive EEG characteristics
- Women and men of childbearing potential agree to use medically acceptable contraception
- Voluntary participation with signed informed consent form
You will not qualify if you...
- Dementia or severe neurological, psychiatric, or systemic diseases that are poorly controlled or interfere with the trial
- Pregnant or breastfeeding women
- History of suicide attempt or suicidal behavior
- Other neurological diseases with symptoms similar to ALS or affecting drug efficacy evaluation, such as cervical spondylotic myelopathy, lumbar spondylosis, or dementia
- History of spinal surgery after ALS onset
- Elevated liver enzymes (ALT or AST > 2 times upper limit of normal) or creatinine clearance < 60 mL/min/1.73m2
- Allergic to the investigational product
- Participation in other clinical studies within 3 months before randomization
- Considered unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
S
Sun Can
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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