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A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease

NCT04428775 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-11-08

No results posted yet for this study

Summary

This is a Phase IIa, randomized, open-label, multi-center, multi-dose study for subjects with mild to moderate ALS. The protocol is designed to determine whether ALZT-OP1a treatment will positively impact neuro-inflammatory biomarkers and slow down or arrest functional decline in subjects with mild to moderate ALS.

Conditions

Interventions

DRUG

ALZT-OP1a (cromolyn)

1. Mast cell stabilizer 2. Neuroinflammatory microglial modulator 3. anti-inflammatory

Sponsors & Collaborators

  • AZTherapies, Inc.

    lead INDUSTRY

Principal Investigators

  • David R. Elmaleh, PhD · AZTherapies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2021-10-01
Completion
2021-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04428775 on ClinicalTrials.gov