This is a Phase II clinical trial evaluating the effectiveness and safety of an investigational drug, FHND1002 granules, in adults with Amyotrophic Lateral Sclerosis (ALS).
The main goals are:
To determine if FHND1002 can slow the progression of ALS compared to a placebo.
To assess the safety and tolerability of two different doses of FHND1002 (100mg and 200mg) in ALS patients.
Approximately 180 participants will be randomly assigned (like flipping a coin) to one of three groups:
FHND1002 100mg once daily
FHND1002 200mg once daily
Placebo (an inactive substance) once daily Assignment will consider disease severity (ALSFRS-R score) and where symptoms started (Limb vs. Bulbar). Participants can continue taking stable doses of approved ALS medications (like riluzole or edaravone) or be on no medication.
The study consists of:
A Screening Period (up to 4 weeks).
A Double-Blind Treatment Period (48 weeks).
During the 48-week treatment period:
Participants will take their assigned granules orally once daily (with or without food).
They will attend clinic visits at Weeks 2, 4, 12, 24, 36, and 48 for safety checks.
Effectiveness will be measured at Weeks 12, 24, 36, and 48 using standard ALS assessments, including the ALS Functional Rating Scale-Revised (ALSFRS-R), breathing tests (FVC%), and quality of life/questionnaires (ROADS, ALSAQ-5).