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Arimoclomol in Amyotropic Lateral Sclerosis

NCT03491462 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2023-08-24

Study results available
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Summary

A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)

Conditions

Interventions

DRUG

Arimoclomol

2 capsules (2 x 124 mg arimoclomol base; equivalent to 2 x 200 mg arimoclomol citrate) taken 3 times daily

DRUG

Placebo

2 matched placebo capsules taken 3 times daily

Sponsors & Collaborators

  • ZevraDenmark

    lead INDUSTRY

Principal Investigators

  • Michael Benatar, MD PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2020-12-18
Completion
2020-12-18
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03491462 on ClinicalTrials.gov