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Tests treatment safety and results for Sporadic and Familial Amyotrophic Lateral Sclerosis
Official title Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
ClinicalTrials.gov ID: NCT05923905
What this study is testing
What is FB1006?
FB1006 is an investigational medicine, being studied as a potential treatment for sporadic and familial amyotrophic lateral sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- World Federation of Neurology modified El Ecorial criteria for diagnosis of patients with laboratory support probable, clinically probable, or...
- 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
You likely can't join if
- Patients with dementia or severe neurological, psychiatric or systemic disease that is poorly controlled or may interfere with the conduct of the...
- 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 how well it works, such as cervical...
- Patients with history of spinal surgery after ALS onset
- ALT or AST \> 2 times ULN，creatinine clearance \< 60 mL/min/1.73m2 (MDRD)
See the full eligibility 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
- 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 how well it works, 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
- Patients that the investigator considers unsuitable for participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.