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

  • STATUS
    Recruiting
  • participants needed
    9
  • sponsor
    Mitsubishi Tanabe Pharma Corporation
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Updated on 19 February 2024
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Summary

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

Details
Condition Japanese Patients With ALS
Age 20-80 years
Treatment MT-1186
Clinical Study IdentifierNCT04254913
SponsorMitsubishi Tanabe Pharma Corporation
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

The key criteria are listed below
Patients aged between 20 and 80 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
ALS Patients with gastrostomy
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 <15.0 or >30.0, or a body weight of <40 kg
Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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