Amyotrophic Lateral Sclerosis (ALS) Clinical Trial
Official title:
A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.
This is an extension study which consists of two phases:
Double-blind phase; Patients will continue to take blinded study medication, as allocated in
study ONO-2506POE014 by the central randomization system, in the presence of stable standard
Riluzole therapy, until un-blinding of the study results.
Open label phase; Patients who were allocated to ONO-2506PO in the ONO-2506POE014 study will
be offered entry into the open label phase of ONO-2506POE015 study and will continue to take
1200 mg of ONO-2506PO for the duration of their participation in the study, in the presence
of stable standard Riluzole therapy. Patients who were allocated to placebo in
ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be
followed up by their site with standard care.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02365922 -
Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)
|
||
| Completed |
NCT01699451 -
DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida
|
||
| Completed |
NCT04577404 -
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 3 | |
| Terminated |
NCT03580616 -
Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| Completed |
NCT02118805 -
Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
|
||
| Completed |
NCT01884571 -
Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| Completed |
NCT00244244 -
A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS
|
Phase 2 | |
| Active, not recruiting |
NCT00420719 -
Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS)
|
N/A | |
| Completed |
NCT02936635 -
A Study for Patients Who Completed VITALITY-ALS (CY 4031)
|
Phase 3 | |
| Withdrawn |
NCT04055532 -
Biomarkers in Neurodegenerative Diseases
|
||
| Completed |
NCT03645031 -
Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease
|
N/A | |
| Completed |
NCT01786603 -
Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| Completed |
NCT02559869 -
Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
|
||
| Completed |
NCT01592552 -
A Biospecimen and Clinical Data Study on Patients for Drug & Biomarker Discovery
|
||
| Completed |
NCT00403104 -
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| Recruiting |
NCT02424669 -
Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients
|
N/A | |
| Completed |
NCT02017912 -
Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS
|
Phase 2 | |
| Completed |
NCT01366027 -
PRISM Registry: Pseudobulbar Affect Registry Series
|
N/A | |
| Completed |
NCT00330681 -
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
|
Phase 3 | |
| Completed |
NCT00876772 -
Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2/Phase 3 |