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.
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. The study has two phases: the first phase is 24 weeks, using a randomized double-blind placebo-controlled design; the second phase is 24 weeks, using an open-label study design. FB1006 was approved by the National Medical Products Administration（NMPA）on June 21, 2021.
Inclusion Criteria:
1. World Federation of Neurology modified El Ecorial criteria for diagnosis of patients
with laboratory support probable, clinically probable, or definite sporadic and
familial amyotrophic lateral sclerosis (ALS)
2. Age 18 to 80 years old
3. ALS duration no longer than 18 months(from day of onset)
4. Patient 's ALSFRS-R total scored ≥27，Each single item is scored at least 2（dyspnoea,
orthopnea and respiratory insufficiency ≥3）
5. Forced vital capacity (FVC%) no less than 70% of predicted normal for gender, height
and age
6. According to brain function AI analysis in accordance with depressive EEG
characteristics
7. Women and men of childbearing potential should use medically acceptable contraception
8. Voluntarily participate, and sign an informed consent form
Exclusion Criteria:
1. Patients with dementia or severe neurological, psychiatric or systemic disease that is
poorly controlled or may interfere with the conduct of the trial or the results of the
trial
2. Pregnant women and lactating women
3. Suicide attempt or attempted suicide
4. Combined with other neurological diseases similar to ALS symptoms, or affecting the
evaluation of drug efficacy, such as cervical spondylotic myelopathy, lumbar
spondylosis, dementia, etc.
5. Patients with history of spinal surgery after ALS onset
6. ALT or AST > 2 times ULN，creatinine clearance < 60 mL/min/1.73m2 (MDRD)
7. Patients who are allergic to the investigational product
8. Having participated in other clinical studies within 3 months before randomization
9. Patients that the investigator considers unsuitable for participation in the study