Sporadic and Familial Amyotrophic Lateral SclerosisPhase 4FB1006NCT05923905
Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
A Phase 4 study testing FB1006 in people with Sporadic and Familial Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sporadic and Familial Amyotrophic Lateral Sclerosis
- What is being tested?
- FB1006
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2023to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Sun Can, +86-10-82265791, scdoctor@qq.com
About this study
Official title: Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
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.
Read the 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.
- Being tested
- FB1006, Placebo
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB1006Drug
30mg/day
PlaceboDrug
30mg/day
| Study group | Role | What they receive |
|---|---|---|
| FB1006 test group | Experimental | Take FB1006 at night,30mg/day Receives: Drug: FB1006 |
| placebo group | Placebo comparator | Take placebo at night,30mg/day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (12)
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.
Measured: 24 weeks
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.
Measured: 12 weeks, 36 weeks, and 48 weeks
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.
Measured: 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
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.
Measured: 12 weeks, 24 weeks, 36 weeks, and 48 weeks
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.
Measured: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, and 48 weeks.
Metabolic Level
Changes in metabolic equivalent (MET) value during the observation period. MET is measured by cardiopulmonary exercise test (CPET).
Measured: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
FVC% (Forced Vital Capacity)
Changes in FVC% during the observation period.
Measured: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Body Weight
Changes in body weight during the observation period.
Measured: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
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.
Measured: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
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.
Measured: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Language Disorders
Occurrence of language disorders during the observation period. Language disorders is detected by AI (Artificial Intelligence) analysis from wearable electroencephalographic device.
Measured: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
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.
Measured: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start18 Jan 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sporadic and Familial Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fan DongSheng, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923905
- Sponsor's protocol ID
- M2022300
- Acronym
- FB1006
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
- ClinicalTrials.gov ID
- NCT05923905
- Acronym / sponsor ID
- FB1006 / M2022300
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FB1006 test group | Experimental | Drug: FB1006Take FB1006 at night,30mg/day |
| placebo group | Placebo comparator | Drug: PlaceboTake placebo at night,30mg/day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FB100630mg/day | Drug | FB1006 test group |
| Placebo30mg/day | Drug | placebo group |
Primary outcome
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.
12 secondary outcomes
ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) Score
Time frame: 24 weeks
ALSFRS-R Score
Time frame: 12 weeks, 36 weeks, and 48 weeks
ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score
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
ALSAQ-40 (Amyotrophic Lateral Sclerosis Assessment Questionnaire-40) Score
Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks
Zung 's Self-Rating Depression Scale
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.
Metabolic Level
Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
FVC% (Forced Vital Capacity)
Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Body Weight
Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
MRC (Medical Research Council) Scale
Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
MUNIX (Motor Unit Number Index)
Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Language Disorders
Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Hand Delicate Function
Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fan DongSheng principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FB1006 in people with Sporadic and Familial Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun Can (+86-10-82265791, scdoctor@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.