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Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04176224
Recruitment Status : Completed
First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis

Condition or disease Intervention/treatment Phase
Japanese Patients With ALS Drug: MT-1186 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)
Actual Study Start Date : April 17, 2019
Actual Primary Completion Date : September 4, 2019
Actual Study Completion Date : September 4, 2019


Arm Intervention/treatment
Experimental: MT-1186
Patients receive the edaravone oral suspension.
Drug: MT-1186
Suspension
Other Name: Edaravone




Primary Outcome Measures :
  1. Plasma concentrations of edaravone [ Time Frame: Day 1 to 2 ]
  2. Urine concentrations of edaravone [ Time Frame: Day 1 to 2 ]
  3. Area under the concentration versus time curve (AUC) of edaravone [ Time Frame: Day 1 to 2 ]
  4. Maximum plasma concentration (Cmax) of edaravone [ Time Frame: Day 1 to 2 ]
  5. Time to reach maximum plasma concentration (tmax) of edaravone [ Time Frame: Day 1 to 2 ]
  6. Terminal elimination half-life (t1/2) of edaravone [ Time Frame: Day 1 to 2 ]
  7. Apparent terminal elimination rate constant (Kel) of edaravone [ Time Frame: Day 1 to 2 ]
  8. Mean residence time (MRT) of edaravone [ Time Frame: Day 1 to 2 ]
  9. Apparent total clearance (CL/F) of edaravone [ Time Frame: Day 1 to 2 ]
  10. Apparent distribution volume at elimination phase (Vz/F) of edaravone [ Time Frame: Day 1 to 2 ]
  11. Apparent distribution volume at steady state (Vss/F) of edaravone [ Time Frame: Day 1 to 2 ]
  12. Cumulative amount of drug excreted in urine (Ae) of edaravone [ Time Frame: Day 1 to 2 ]
  13. Cumulative percentage of drug excreted in urine (Ae%) of edaravone [ Time Frame: Day 1 to 2 ]
  14. Apparent renal clearance (CLr/F) of edaravone [ Time Frame: Day 1 to 2 ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse events and adverse drug reactions [ Time Frame: The provision of informed consent to Day 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The key criteria are listed below.

  • Patients aged between 20 and 75 years at the time of informed consent
  • Japanese patients
  • Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie House criteria
  • Patients who can consent to contraception
  • Patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

The key criteria are listed below.

  • Patients in whom the possibility could not be ruled out that the current symptoms were symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy
  • Patients undergoing treatment for malignancy
  • Patients who have presence of clinically significant liver, heart, or renal disease requiring hospitalization (except ALS) and infections requiring antibiotics. Patients who have a problem in general condition and are judged ineligible by the Investigator
  • Body mass index (BMI) of <18.0 or >30.0, or a body weight of <50 kg
  • Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176224


Locations
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Japan
Investigational site
Tokyo, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT04176224    
Other Study ID Numbers: MT-1186-J04
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Edaravone
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs