Clinical trials: sponsored by 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
Healthy Adult Subjects
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males Cohort 2: To evaluate the pharmacokinetics, safety…
- Trial name
- NCT04481789
- Testing
- MT-1186, Rosuvastatin, Sildenafil
- Where
- Japan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Shionogi
Renal Impairment, Healthy
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate renal impairment compared to subjects with normal renal function.
- Trial name
- NCT03289208
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Adult Subjects
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study)
To evaluate the effect of food on the pharmacokinetics of oral edaravone in healthy adult subjects. In this study, we determined 5 different dietary conditions including 4 different meal contents and fasting condition.
- Trial name
- NCT05342597
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Adult Subjects
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV) formulation of edaravone in the fasting state in healthy adult subjects
- Trial name
- NCT04493281
- Testing
- MT-1186, MCI-186
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Adult Subjects
A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects
To evaluate the effect of MCI-186 on the QT interval corrected for heart rate using Fridericia's formula (QTcF)
- Trial name
- NCT04029090
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis, ALS
Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)
REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS.
- Trial name
- NCT04259255
- Testing
- Edaravone (Radicava®/Radicava ORS®)
- Where
- 20 sites in United States, Canada
- Volunteers
- 74 people
- Sponsor
- Shionogi
Pompe Disease
Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD)
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and exploratory clinical efficacy of S-606001 in adult participants with LOPD as an add-on to ERT.
- Trial name
- NCT07123155
- Testing
- S-606001
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 45 people
- Sponsor
- Shionogi
Jordan's Syndrome, PPP2R5D Neurodevelopmental Disorder
Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS])
The primary objective of this study is to assess the efficacy, safety, and tolerability of BPN14770 in participants aged 9 to 45 years with JS.
- Trial name
- NCT06717438
- Testing
- BPN14770
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Shionogi
Sleep Apnea
Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea
The primary purpose of this study is to evaluate the effectiveness of sivopixant, acetazolamide and SASS-001 in adults with sleep apnea with a central component.
- Trial name
- NCT06776432
- Testing
- Sivopixant, Acetazolamide, SASS-001
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Shionogi