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Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis

NCT07023835 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-02-05

No results posted yet for this study

Summary

Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

50 mg Usnoflast

50 mg Usnoflast (50 mg Usnoflast capsules and matching placebo of 25 mg capsule)

DRUG

75 mg Usnoflast

75 mg Usnoflast (25 mg + 50 mg Usnoflast capsules)

DRUG

Placebo

Matching placebo of 25 mg and 50 mg

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Deven V Parmar · Zydus Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-17
Primary Completion
2028-03-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT07023835 on ClinicalTrials.gov