Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Sporadic and Familial Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID: NCT05923905
Run by: Peking University Third Hospital
People needed: 64
Starts: 2023-01-18
Expected to finish: 2027-09-30
Last updated by the study team: 2023-11-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)
Age 18 to 80 years old
ALS duration no longer than 18 months(from day of onset)
Patient 's ALSFRS-R total scored ≥27，Each single item is scored at least 2（dyspnoea, orthopnea and respiratory insufficiency ≥3）
Forced vital capacity (FVC%) no less than 70% of predicted normal for gender, height and age
According to brain function AI analysis in accordance with depressive EEG characteristics
Women and men of childbearing potential should use medically acceptable contraception
Voluntarily participate, and sign an informed consent form

You may not qualify if…

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
Pregnant women and lactating women
Suicide attempt or attempted suicide
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.
Patients with history of spinal surgery after ALS onset
ALT or AST > 2 times ULN，creatinine clearance < 60 mL/min/1.73m2 (MDRD)
Patients who are allergic to the investigational product
Having participated in other clinical studies within 3 months before randomization
Patients that the investigator considers unsuitable for participation in the study

Where it is running

Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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