Testing FB1006 against placebo in people with ALS
Tests the drug FB1006 against a placebo in adults with ALS.
Plain-language title generated from the registry record
Registry title: Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05923905, who can take part
Where in China
- Peking University Third HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University Third Hospital
- Trial code
- NCT05923905
- Record updated
- 22 November 2023
- Original description
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.Read full original descriptionShow less
Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of 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.
Inclusion: 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: Patients who are allergic to the investigational product; Having participated in other clinical studies within 3 months before randomization; 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; 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); Pregnant women and lactating women; Suicide attempt or attempted suicide; Patients that the investigator considers unsuitable for participation in the study.