RecruitingPhase 4

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

China64 participantsStarted 2023-01-18

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score

Timeframe: 24 weeks

Trial details

NCT IDNCT05923905

SponsorPeking University Third Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Sun Can

+86-10-82265791 scdoctor@qq.com

View on ClinicalTrials.gov More Sporadic and Familial Amyotrophic Lateral Sclerosis trials