Safety Extension Study of TRO19622 in ALS

Status Completed

Clinical Trial Summary

The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.

Clinical Trial Description

Entry of a patient into this safety study is intended to occur immediately after the patient has finished participating in the preceding efficacy study (Protocol TRO19622 CL E Q 1015-1).

The Investigator will explain to the patients the nature of this open-label safety study, its procedures, requirements and restrictions so as to obtain their written informed consent.

Each patient will be treated with olesoxime (TRO19622) until the results of the double-blind trial become available with a maximum of 15 months.

Follow-up visits will take place every 3 months (+/- 2 weeks).

Safety assessments will be performed at all visits (every 3 months). ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01285583
Study type	Interventional
Source	Hoffmann-La Roche
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	October 2010
Completion date	March 2012

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	`NCT06450691` - Modeling Amyotrophic Lateral Sclerosis With Fibroblasts	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
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