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Arimoclomol in Amyotropic Lateral Sclerosis | Clinical Trials | Clareo Health

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COMPLETEDPhase 3NCT03491462

Arimoclomol in Amyotropic Lateral Sclerosis

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

Lead sponsor: ZevraDenmark•10 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

ZevraDenmark

Screening up to 4 weeks Treatment up to 76 weeks

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Subject meets revised El Escorial criteria for clinically possible, clinically probable / clinically probable ALS laboratory-supported, clinically definite ALS or clinically definite familial ALS laboratory-supported
•18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria, dysphagia, shortness of breath)
•ALS Functional Rating Scale-Revised (ALSFRS-R) equal to or above 35 and erect (seated) Slow Vital Capacity (SVC) % predicted equal to or above 70% at Screening

Exclusion Criteria

•Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking hours at the time of Screening and Baseline
•Pregnant or breast-feeding
•Current or anticipated use of diaphragmatic pacing
•Any other relevant medically significant condition which could present risk to the subject or interfere with the assessment of safety or has an increased risk of causing death during the trial

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 24, 2023Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment245

Start dateJul 2018

Last updatedAug 24, 2023

Condition

Amyotrophic Lateral Sclerosis

Locations shown

St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

Phoenix, Arizona

HonorHealth Neurology

Phoenix, Arizona

UC Irvine Health ALS and Neuromuscular Center

Orange, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2023Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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