Evaluating FB1006 for treating ALS patients
Official title: Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
Run by Peking University Third Hospital · NCT05923905 · Data updated 2026-11-12
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 | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 18, 2023 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | November 22, 2023 |
| Trial ID | NCT05923905 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 to 80 with a confirmed diagnosis of ALS and specific health metrics.
✕Probably not a fit
Patients with severe neurological or psychiatric conditions that could interfere with the trial may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from ALS.
How similar studies have gone: While this approach is exploratory, similar studies have shown promise in evaluating new treatments for ALS.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Fan DongSheng — Peking University Third Hospital
- Study coordinator: Sun Can
- Email: scdoctor@qq.com
- Phone: +86-10-82265791
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.