NCT05923905RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 22 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 6 Feb 2023
- Start date
- 18 Jan 2023
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Peking University Third Hospital
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05923905
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 64
- From 18 Jan 2023 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are allergic to the investigational product
- Having participated in other clinical studies within 3 months before randomization
Other illness
- 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
Lab values
- ALT or AST \> 2 times ULN，creatinine clearance \< 60 mL/min/1.73m2 (MDRD)
Other
- Pregnant women and lactating women
- Suicide attempt or attempted suicide
- Patients that the investigator considers unsuitable for participation in the study
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.