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

Peking University Third Hospital1 site in 1 country64 target enrollmentJanuary 18, 2023

ConditionsSporadic and Familial Amyotrophic Lateral Sclerosis

InterventionsFB1006 Placebo

DrugsFB1006 Placebo

Overview

Phase: Phase 4
Intervention: FB1006
Conditions: Sporadic and Familial Amyotrophic Lateral Sclerosis
Sponsor: Peking University Third Hospital
Enrollment: 64
Locations: 1
Primary Endpoint: ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed 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. The study has two phases: the first phase is 24 weeks, using a randomized double-blind placebo-controlled design; the second phase is 24 weeks, using an open-label study design. FB1006 was approved by the National Medical Products Administration（NMPA）on June 21, 2021.

Registry

clinicaltrials.gov

Start Date

January 18, 2023

End Date

September 30, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking University Third Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion 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

Exclusion Criteria

•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 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)
•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

Arms & Interventions

FB1006 test group

Take FB1006 at night,30mg/day

Intervention: FB1006

placebo group

Take placebo at night,30mg/day

Intervention: Placebo

Outcomes

Primary Outcomes

ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score

Time Frame: 24 weeks

Changes in ROADS from baseline to 24 weeks. ROADS score ranges from 0 to 56 points, and higher scores indicate better basic daily function.

Secondary Outcomes

ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) Score(24 weeks)
FVC% (Forced Vital Capacity)(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
Metabolic Level(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
MRC (Medical Research Council) Scale(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
Hand Delicate Function(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
ALSFRS-R Score(12 weeks, 36 weeks, and 48 weeks)
MUNIX (Motor Unit Number Index)(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
Language Disorders(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score(4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, and 48 weeks)
ALSAQ-40 (Amyotrophic Lateral Sclerosis Assessment Questionnaire-40) Score(12 weeks, 24 weeks, 36 weeks, and 48 weeks)
Zung 's Self-Rating Depression Scale(4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, and 48 weeks.)
Body Weight(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)