NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)

CompletedPhase 3

Sponsor: Shionogi

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Interventions: MCI-186, Placebo of MCI-186

Countries: Japan

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 assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681.

Exclusion Criteria:

* Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone.
* Patients whose creatinine clearance is 50mL/min or less at the time of completion of drug administration in the study NCT00330681.
* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
* Patients who are participating in other clinical trials except the study NCT00330681.
* In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

Locations (1)

Watari-gun, Miyagi, Japan