Clinical trials: Als
ALS
Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point…
- Trial name
- NCT05151471
- Testing
- MT-1186
- Where
- 37 sites in United States, Canada and 4 more
- Volunteers
- 202 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis, ALS
Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis
This is a clinical trial to evaluate the safety, tolerability, and biological effect of LAM-002A in adults with C9ORF72-associated ALS (C9ALS).
- Trial name
- NCT05163886
- Testing
- LAM-002A
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- IRulya Therapeutics Inc.
Amyotrophic Lateral Sclerosis (ALS)
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24…
- Trial name
- NCT00330681
- Testing
- MCI-186
- Volunteers
- 206 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis (ALS)
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III
The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, based on the changes in the revised ALS functional…
- Trial name
- NCT00415519
- Testing
- MCI-186
- Volunteers
- 25 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis (ALS)
Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel…
- Trial name
- NCT00424463
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 181 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis (ALS)
Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores…
- Trial name
- NCT01492686
- Testing
- MCI-186, MCI-186 in open label phase
- Where
- Japan
- Volunteers
- 137 people
- Sponsor
- Shionogi
ALS
Safety Study of Oral Edaravone Administered in Subjects With ALS
The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.
- Trial name
- NCT04165824
- Testing
- MT-1186
- Where
- 53 sites in United States, Canada and 4 more
- Volunteers
- 185 people
- Sponsor
- Shionogi
ALS
Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS
The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period.
- Trial name
- NCT05568615
- Testing
- MT-1186
- Where
- 11 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Shionogi
ALS
Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS) based on the change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to…
- Trial name
- NCT04569084
- Testing
- MT-1186
- Where
- 95 sites in United States, Canada and 5 more
- Volunteers
- 384 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis (ALS)
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral…
- Trial name
- NCT04577404
- Testing
- MT-1186
- Where
- 44 sites in United States, Canada and 4 more
- Volunteers
- 124 people
- Sponsor
- Shionogi
Japanese Patients With ALS
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy
- Trial name
- NCT04254913
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Shionogi
Japanese Patients With ALS
Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis
- Trial name
- NCT04176224
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis, ALS
Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol)
Prospective, international, randomised, double-blind, placebo controlled, multicentre, parallel group study. Patients will be randomised in a 2:1 allocation ratio to receive either IFB-088 + riluzole 100 mg or placebo + riluzole…
- Trial name
- NCT05508074
- Testing
- IFB-088 50mg/day, Riluzole 100mg/day
- Where
- 9 sites in France, Italy
- Volunteers
- 51 people
- Sponsor
- InFlectis BioScience
ALS Caused by Superoxide Dismutase 1 (SOD1) Mutation
Long-Term Evaluation of BIIB067 (Tofersen)
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 (tofersen) in participants with amyotrophic lateral sclerosis (ALS) and confirmed superoxide dismutase 1 (SOD1) mutation.
- Trial name
- NCT03070119
- Testing
- Tofersen
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 139 people
- Sponsor
- Biogen
Amyotrophic Lateral Sclerosis, ALS
Open Label Extension Study of AMX0035 in Patients With ALS
This extension study, in which all participants received active treatment (AMX0035), was designed to assess the longer-term safety and therapeutic potential of AMX0035 for participants who have completed the Main Study (AMX3500…
- Trial name
- CENTAUR-OLE (NCT03488524)
- Testing
- AMX0035
- Where
- 24 sites in United States
- Volunteers
- 90 people
- Sponsor
- Amylyx Pharmaceuticals Inc.
Amyotrophic Lateral Sclerosis (ALS)
Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS
This is a multi-center, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of autologous (self) transplantation of Neurotrophic factors-secreting Mesenchymal Stromal Cells (MSC-NTF, NurOwn™) in…
- Trial name
- NurOwn (NCT02017912)
- Testing
- Nurown MSC-NTF cells
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- Brainstorm-Cell Therapeutics
Amyotrophic Lateral Sclerosis (ALS)
Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients
This study will evaluate the safety and efficacy of repeated administration of NurOwn® (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal cells (MSC), which are…
- Trial name
- NCT03280056
- Testing
- NurOwn® (MSC-NTF cells), Bone Marrow aspiration
- Where
- 6 sites in United States
- Volunteers
- 196 people
- Sponsor
- Brainstorm-Cell Therapeutics
Amyotrophic Lateral Sclerosis, ALS
An Efficacy and Safety Study of Ravulizumab in ALS Participants
The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.
- Trial name
- NCT04248465
- Testing
- Ravulizumab
- Where
- 95 sites in United States, Australia and 15 more
- Volunteers
- 382 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Amyotrophic Lateral Sclerosis, ALS
Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells("HYNR-CS inj"), through intrathecal delivery for the treatment in patients with ALS. This study consists of 2 steps.
- Trial name
- NCT01363401
- Testing
- HYNR-CS inj, Control group
- Where
- South Korea
- Volunteers
- 72 people
- Sponsor
- Corestemchemon, Inc.
Amyotrophic Lateral Sclerosis (ALS)
A Study for Patients Who Completed VITALITY-ALS (CY 4031)
The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).
- Trial name
- VIGOR-ALS (NCT02936635)
- Testing
- tirasemtiv
- Where
- 67 sites in United States, Belgium and 9 more
- Volunteers
- 280 people
- Sponsor
- Cytokinetics