Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial

Status Terminated

Clinical Trial 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.

Clinical Trial Description

The planned duration of the open-label trial was 152 weeks, but the trial was terminated early as a consequence of the results of ORARIALS-01 which did not meet any of its efficacy endpoints. Therefore, the actual mean duration of open-label treatment was approximately 28 weeks (range approximately 2 to 71 weeks). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03836716
Study type	Interventional
Source	ZevraDenmark
Contact
Status	Terminated
Phase	Phase 3
Start date	September 19, 2019
Completion date	July 2, 2021

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04428775` - A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease	Phase 2
Recruiting	`NCT04998305` - TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps	Phase 1/Phase 2
Recruiting	`NCT05951556` - Telehealth Implementation of Brain-Computer Interface	N/A
Terminated	`NCT04579666` - MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)	Phase 2
Recruiting	`NCT04082832` - CuATSM Compared With Placebo for Treatment of ALS/MND	Phase 2/Phase 3
Completed	`NCT01925196` - Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
Completed	`NCT02496767` - Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year	Phase 3
Recruiting	`NCT04816227` - Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
Active, not recruiting	`NCT04494256` - A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation	Phase 1/Phase 2
Completed	`NCT03706391` - Study of ALS Reversals 4: LifeTime Exposures
Recruiting	`NCT04882904` - Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.	N/A
Completed	`NCT04557410` - Open Label Study: Treatment of ALS Fatigue With PolyMVA	Phase 1
Active, not recruiting	`NCT04948645` - A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis	Phase 1
Not yet recruiting	`NCT04089696` - Validation of the "ExSpiron©" in Patients With ALS	N/A
Not yet recruiting	`NCT04220190` - RAPA-501 Therapy for ALS	Phase 2/Phase 3
Not yet recruiting	`NCT05860244` - Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients	Phase 2
Not yet recruiting	`NCT06450691` - Modeling Amyotrophic Lateral Sclerosis With Fibroblasts	N/A
Recruiting	`NCT02917681` - Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis	Phase 1/Phase 2
Active, not recruiting	`NCT03067857` - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease	Phase 1/Phase 2
Recruiting	`NCT02874209` - Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis	N/A