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

Primary Purpose

Sporadic and Familial Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
FB1006
Placebo
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sporadic and Familial Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FB1006 test group

placebo group

Arm Description

Take FB1006 (Mirtazapine tablets) at night,30mg/day

Take placebo at night,30mg/day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) Score
Changes in ALSFRS-R from baseline to 24 weeks. ALSFRS-R score ranges from 0 to 48 points, and higher scores indicate milder functional impairment.
ALSFRS-R Score
Changes in ALSFRS-R and slope of score decrease during the observation period. ALSFRS-R score ranges from 0 to 48 points, and higher scores indicate better function.
ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score
Changes in ROADS during the observation period. ROADS score ranges from 0 to 56 points, and higher scores indicate better basic daily function.
ALSAQ-40 (Amyotrophic Lateral Sclerosis Assessment Questionnaire-40) Score
Changes in ALSAQ-40 during the observation period. ALSAQ-40 score ranges from 0 to 160 points, and higher scores indicate better quality of life.
Zung 's Self-Rating Depression Scale
Changes in Zung 's score during the observation period. Zung 's score ranges from 0 to 100 points, and higher scores indicate more severity of depression.
Metabolic Level
Changes in metabolic equivalent (MET) value during the observation period. MET is measured by cardiopulmonary exercise test (CPET).
FVC% (Forced Vital Capacity)
Changes in FVC% during the observation period.
Body Weight
Changes in body weight during the observation period.
MRC (Medical Research Council) Scale
Changes in MRC classification during the observation period. MRC ranges from 0 to V grades, and higher grades indicate higher muscle strength.
MUNIX (Motor Unit Number Index)
Changes in MUNIX during the observation period. MUNIX is obtained from electromyography (EMG) in terms of quadriceps, deltoid, abductor digiti minimi (ADM), and tibialis anterior (TA) muscles.
Language Disorders
Occurrence of language disorders during the observation period. Language disorders is detected by AI (Artificial Intelligence) analysis from wearable electroencephalographic device.
Hand Delicate Function
Changes in hand delicate function during the observation period. Hand delicate function is detected by AI (Artificial Intelligence) analysis from wearable electromyographic device.

Full Information

First Posted
February 6, 2023
Last Updated
August 9, 2023
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05923905
Brief Title
Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
Acronym
FB1006
Official Title
Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (Mirtazapine tablets) was approved by the National Medical Products Administration(NMPA)on June 21, 2021.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sporadic and Familial Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FB1006 test group
Arm Type
Experimental
Arm Description
Take FB1006 (Mirtazapine tablets) at night,30mg/day
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Take placebo at night,30mg/day
Intervention Type
Drug
Intervention Name(s)
FB1006
Intervention Description
30mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
30mg/day
Primary Outcome Measure Information:
Title
ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score
Description
Changes in ROADS from baseline to 24 weeks. ROADS score ranges from 0 to 56 points, and higher scores indicate better basic daily function.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) Score
Description
Changes in ALSFRS-R from baseline to 24 weeks. ALSFRS-R score ranges from 0 to 48 points, and higher scores indicate milder functional impairment.
Time Frame
24 weeks
Title
ALSFRS-R Score
Description
Changes in ALSFRS-R and slope of score decrease during the observation period. ALSFRS-R score ranges from 0 to 48 points, and higher scores indicate better function.
Time Frame
12 weeks, 36 weeks, and 48 weeks
Title
ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score
Description
Changes in ROADS during the observation period. ROADS score ranges from 0 to 56 points, and higher scores indicate better basic daily function.
Time Frame
4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, and 48 weeks
Title
ALSAQ-40 (Amyotrophic Lateral Sclerosis Assessment Questionnaire-40) Score
Description
Changes in ALSAQ-40 during the observation period. ALSAQ-40 score ranges from 0 to 160 points, and higher scores indicate better quality of life.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks
Title
Zung 's Self-Rating Depression Scale
Description
Changes in Zung 's score during the observation period. Zung 's score ranges from 0 to 100 points, and higher scores indicate more severity of depression.
Time Frame
4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, and 48 weeks.
Title
Metabolic Level
Description
Changes in metabolic equivalent (MET) value during the observation period. MET is measured by cardiopulmonary exercise test (CPET).
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
FVC% (Forced Vital Capacity)
Description
Changes in FVC% during the observation period.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
Body Weight
Description
Changes in body weight during the observation period.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
MRC (Medical Research Council) Scale
Description
Changes in MRC classification during the observation period. MRC ranges from 0 to V grades, and higher grades indicate higher muscle strength.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
MUNIX (Motor Unit Number Index)
Description
Changes in MUNIX during the observation period. MUNIX is obtained from electromyography (EMG) in terms of quadriceps, deltoid, abductor digiti minimi (ADM), and tibialis anterior (TA) muscles.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
Language Disorders
Description
Occurrence of language disorders during the observation period. Language disorders is detected by AI (Artificial Intelligence) analysis from wearable electroencephalographic device.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
Hand Delicate Function
Description
Changes in hand delicate function during the observation period. Hand delicate function is detected by AI (Artificial Intelligence) analysis from wearable electromyographic device.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Other Pre-specified Outcome Measures:
Title
Important Events in ALS Progression
Description
Occurrence of important events in ALS Progression, include indwelling gastric tube/gastrostomy, respiratory support, death, etc.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
ESS (Epworth Sleepiness Scale) Score
Description
Changes in ESS score during the observation period. ESS score ranges from 0 to 24 points, and higher scores indicate more severity of daytime somnolence.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
PSQI (Pittsburgh Sleep Quality Index) Score
Description
Changes in PSQI during the observation period. PSQI score ranges from 0 to 21 points, and higher scores indicate poorer sleep quality.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
Biomarkers
Description
Changes in serum NFL, BDNF, GDNF, inflammatory factors (TNF, IL-1, IL-6, IL-18, CRP) during the observation period.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
EEG (Electroencephalogram)
Description
Occurrence of clinically significant abnormalities during the observation period.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
CMAP (Compound Muscle Action Potential)
Description
Changes in CMAP during the observation period. CMAP is obtained from electromyography (EMG) in terms of medianus, peroneus, radialis, tibialis, and ulnaris muscles.
Time Frame
12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Title
Adverse Events
Description
Occurrence of any adverse events and clinically significant laboratory abnormalities during the study period.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Can
Phone
+86-10-82265791
Email
scdoctor@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan DongSheng
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Can
Phone
+86-10-82265791
Email
scdoctor@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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