Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients

NCT05923905 | Recruiting Phase 4

• 1 other identifier: M2022300
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Sporadic and Familial Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

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

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

  24 weeks

Secondary Outcomes (12)

• ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) Score

  24 weeks

• ALSFRS-R Score

  12 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.

Other Outcomes (7)

• Important Events in ALS Progression

  12 weeks, 24 weeks, 36 weeks, and 48 weeks.

• ESS (Epworth Sleepiness Scale) Score

  12 weeks, 24 weeks, 36 weeks, and 48 weeks.

• PSQI (Pittsburgh Sleep Quality Index) Score

  12 weeks, 24 weeks, 36 weeks, and 48 weeks.

Study Arms (2)

FB1006 test group

EXPERIMENTAL

Take FB1006 at night,30mg/day

Drug: FB1006

placebo group

PLACEBO COMPARATOR

Take placebo at night,30mg/day

Drug: Placebo

Interventions

FB1006 DRUG

30mg/day

FB1006 test group

Placebo DRUG

30mg/day

placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Fan DongSheng

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Can

CONTACT

+86-10-82265791; scdoctor@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: June 28, 2023
• Study Start: January 18, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 22, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)