NCT07138014

FHND1002 for ALS Treatment: Phase 2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of FHND1002 Granules in Patients With Amyotrophic Lateral Sclerosis (ALS)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

Type	Name	Description
DRUG	FHND1002 100mg	Investigational oral granules containing 100mg FHND1002 (chemical entity: 3-n-butylphthalide derivative). Administered once daily for 48 weeks. Granules are packaged in unit-dose sachets with identical appearance across all study arms. Participants dissolve contents in water prior to ingestion. Stability testing confirms compatibility with fasting or fed conditions.
DRUG	FHND1002 200mg	Investigational oral granules containing 200mg FHND1002 (3-n-butylphthalide derivative). Delivered as two 100mg sachets or one 200mg sachet to maintain blinding. Daily dosing regimen for 48 weeks. Granule composition matches 100mg formulation in excipients and organoleptic properties.
DRUG	Placebo	Placebo granules identical to active intervention in appearance, taste, packaging, and administration method. Contains inert excipients (microcrystalline cellulose, lactose monohydrate) without active

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-12-31
• Completion: 2028-03-01
• First posted: 2025-08-22
• Last updated: 2025-08-22