Evaluating FB1006 for treating ALS patients

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

This study is testing a new treatment called FB1006 to see if it can help people with ALS feel better and stay healthy.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University Third Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05923905 on ClinicalTrials.gov

What this trial studies

This clinical study is designed to assess the efficacy and safety of FB1006 in patients with amyotrophic lateral sclerosis (ALS). It consists of two phases: the first phase is a 24-week randomized double-blind placebo-controlled trial, followed by a 24-week open-label phase. The study aims to enroll patients diagnosed with either sporadic or familial ALS, ensuring they meet specific health criteria. FB1006 has previously received approval from the National Medical Products Administration in 2021.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with a confirmed diagnosis of ALS and specific health metrics.

Not a fit: Patients with severe neurological or psychiatric conditions that could interfere with the trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from ALS.

How similar studies have performed: While this approach is exploratory, similar studies have shown promise in evaluating new treatments for ALS.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing Municipality

• Peking University Third Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Fan DongSheng — Peking University Third Hospital
• Study coordinator: Sun Can

Conditions: Sporadic and Familial Amyotrophic Lateral Sclerosis