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RecruitingPhase 4NCT05923905

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

Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients

Sponsor

Peking University Third Hospital

Enrollment

64 participants

Start Date

Jan 18, 2023

Study Type

INTERVENTIONAL

Conditions

Sporadic and Familial Amyotrophic Lateral Sclerosis

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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

Exclusion Criteria9

  • 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

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Interventions

DRUGFB1006

30mg/day

DRUGPlacebo

30mg/day

Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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NCT05923905