Amyotrophic Lateral Sclerosis
Conditions
Interventions
Experimental group 1:FHND1002 100mg, orally taken once daily
Experimental group 2:FHND1002 200mg, orally taken once daily
Control group:Placeco, orally taken once daily
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects must be >=18 years of age at the time of signing the informed consent form; 2.Subjects must have a diagnosis of Amyotrophic Lateral Sclerosis (ALS) meeting the revised El Escorial World Federation of Neurology criteria categories including Clinically Definite ALS, Clinically Probable ALS, Laboratory-supported Probable ALS, or Clinically Possible ALS; 3.Subjects must demonstrate a documented mean monthly decline of >=0.5 points in the ALS Functional Rating Scale-Revised (ALSFRS-R) score since initial diagnosis; 4.During screening, subjects must exhibit a percent predicted forced vital capacity (FVC%) >=70%; note that use of non-invasive ventilation (NIV) is exclusionary; 5.Disease duration must be =30 with a swallowing function subscore >=2 and all respiratory-related subscores at 4 points; 7.Subjects must have a Body Mass Index (BMI) >=18.5 kg/m². 8.Subjects may or may not be receiving stable therapeutic doses of approved ALS medications (e.g., edaravone, riluzole) prior to enrollment, provided any existing regimen remains unchanged throughout the study; 9.Subjects must demonstrate ability to understand study procedures, willingness to comply, voluntary participation, and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects with coexisting neurological disorders that may mimic ALS symptoms or interfere with efficacy assessment (e.g., cervical/lumbar spondylosis, dementia, history of seizures except childhood febrile seizures) will be excluded; 2.Subjects exhibiting motor conduction block or sensory nerve conduction abnormalities on electromyography (EMG) testing will be excluded; 3.Subjects with any history of spinal surgery within 3 months prior to screening will be excluded; 4.Subjects showing clinically significant laboratory abnormalities at screening including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN), or serum creatinine (Scr) > ULN will be excluded; 5.Subjects with severe/uncontrolled cardiac, hepatic, renal, hematologic, or neoplastic diseases, or active severe psychiatric disorders will be excluded; 6.Exclusion applies to pregnant or lactating women, and subjects planning pregnancy during the study or within 3 months post-treatment; participants of childbearing potential unwilling to use highly effective contraception throughout the study and for 3 months after last dose are excluded; 7.Subjects with known or suspected hypersensitivity to FHND1002 or its excipients will be excluded; 8.Subjects who have participated in another investigational drug/device trial within 1 month prior to screening will be excluded; 9.Subjects deemed by the Investigator to have any condition compromising safety, data integrity, or study compliance will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in ALSFRS-R Total Score at Week 48; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in ROADS Score;Change from Baseline in ALSFRS-R Score (at Weeks 12, 24, 36);Change from Baseline in Percent Predicted Forced Vital Capacity (FVC%);Time to Event (Permanent Ventilator Dependence, Tracheostomy, or Death);Combined Assessment of Function and Survival (CAFS) Score at Week 48; | — |
Countries
China
Contacts
Public ContactDongsheng Fan
Peking University Third Hospital
Outcome results
None listed