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Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial

NCT03836716 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-08-24

Study results available
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Summary

A multicenter, non-randomized, open label trial, to assess long term safety and efficacy of Arimoclomol in subjects with Amyotrophic Lateral Sclerosis (ALS) who have completed the ORARIALS-01 trial.

Conditions

Interventions

DRUG

Arimoclomol

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

Sponsors & Collaborators

  • ZevraDenmark

    lead INDUSTRY

Principal Investigators

  • Michael Benatar, MD PhD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2021-07-02
Completion
2021-07-02
FDA Drug
Yes

Countries

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

Study Locations

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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 NCT03836716 on ClinicalTrials.gov