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A Study to Evaluate the Efficacy and Safety of Different Doses of CB03-154 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT07082192 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-07-24

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if drug CB03-154 works to treat ALS in adults. It will also learn about the safety of drug CB03-154.

The main questions it aims to answer are:

* Does drug CB03-154 have an effect on delaying disease progression, improving function, and prolonging survival in adult ALS patients?
* What medical problems do patients have when taking drug CB03-154? Researchers will compare drug CB03-154 to a placebo (a look-alike substance that contains no drug) to see if drug CB03-154 works to treat ALS.

Participants (adult ALS patients) will:

* Take drug CB03-154 or a placebo every day for 39 weeks (an additional 39 weeks would be required if entering the open-label extension phase).
* Visit the clinic approximately every 2-3 months for checkups and tests, and there is also telephone follow-up in between.
* Keep a diary of daily medication (CB03-154 or other concomitant medications), and if there are any unplanned medications, the reason (disease or symptoms) also need be recorded.

Conditions

  • ALS (Amyotrophic Lateral Sclerosis)

Interventions

DRUG

Test drug CB03-154 5mg group

One CB03-154 tablet (5mg/tablet) once daily.

DRUG

Test drug CB03-154 10mg group

Two CB03-154 tablets (5mg/tablet) once daily.

DRUG

Test drug CB03-154 15mg group

Three CB03-154 tablets (5mg/tablet) once daily.

DRUG

Placebo Group

Three Placebo tablets once daily.

Sponsors & Collaborators

  • Shanghai Zhimeng Biopharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2027-09-30
Completion
2027-10-31

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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 NCT07082192 on ClinicalTrials.gov