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FHND1002 for ALS Treatment: Phase 2

NCT07138014 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-08-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-12-31
Completion
2028-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07138014 on ClinicalTrials.gov