Clinical trials: sponsored by Shionogi
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
Cerebral Infarction
Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.
- Trial name
- NCT00200356
- Testing
- Edaravone, Sodium Ozagrel
- Volunteers
- 401 people
- Sponsor
- Shionogi
SARS-CoV-2 Infection
Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
The purpose of this study is to measure the proportion of participants who are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (positive reverse transcription polymerase chain reaction [RT-PCR] test)…
- Trial name
- SCORPIO-PEP (NCT05897541)
- Testing
- S-217622
- Where
- 178 sites in United States, Argentina and 3 more
- Volunteers
- 3,701 people, healthy volunteers welcome
- Sponsor
- Shionogi
SARS-CoV-2 Infection
A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.
- Trial name
- SCORPIO-HR (NCT05305547)
- Testing
- S-217622
- Where
- 196 sites in United States, Argentina and 15 more
- Volunteers
- 2,093 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
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
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
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
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)
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
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
Acute Ischemic Stroke
Dose Finding Study of MCI-186 in Acute Ischemic Stroke
To investigate the efficacy and safety of MCI-186 (bolus followed by continuous infusion) in acute ischemic stroke patients through a double-blind, parallel-group comparison with the existing MCI-186 dosing regimen…
- Trial name
- NCT03346538
- Testing
- Continuous infusion high-dose MCI-186, Continuous infusion low-dose MCI-186, Approved dosing regimen MCI-186
- Where
- 45 sites in Japan
- Volunteers
- 17 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
Healthy Adult Subjects
Study of Oral Edaravone in Healthy Adult Males
To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males
- Trial name
- NCT04481750
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Shionogi
Acute Ischemic Stroke (AIS)
Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke
The objectives of this study are to assess the safety, tolerability and local tolerance, and to investigate the plasma levels and terminal elimination half life of MCI-186, and to review the routine clinical and neurological…
- Trial name
- NCT00821821
- Testing
- MCI-186
- Where
- 3 sites in Finland, Netherlands and 1 more
- Volunteers
- 36 people
- Sponsor
- Shionogi
Hepatic Impairment, Healthy
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function
- Trial name
- NCT03289234
- Testing
- MCI-186
- Where
- 2 sites in Japan
- Volunteers
- 22 people, healthy volunteers welcome
- 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
Healthy Adult Subjects
Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube
To investigate the comparative bioavailability of edaravone oral suspension administered orally and via a nasogastric tube in healthy adult subjects
- Trial name
- NCT04776135
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shionogi
Severe Hepatic Impairment, Healthy
PK Study in Subjects With Severe Hepatic Impairment
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.
- Trial name
- MCI-186-E05 HP (NCT03664544)
- Testing
- MCI-186
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shionogi