Please refer to ClinicalTrials.gov : NCT03070119.

JRCT ID: jRCT2080225019

Registered date:17/01/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: amyotrophic lateral sclerosis (ALS) with a confirmed mutation in the human superoxide dismutase 1 (SOD1) gene
• Date of first enrollment: 12/03/2020
• Target sample size: 138
• Countries of recruitment: Japan,North America,Europe,Oceania
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code : 19- Other agents affecting nervous system and sensory organs
Dosage and Administration for Investigational material :

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material :

Outcome(s)

Primary Outcome

safety
efficacy
confirmatory
pharmacokinetics
pharmacodynamics
other

Secondary Outcome

exploratory
pharmacokinetics
pharmacodynamics
other

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Please refer to ClinicalTrials.gov : NCT03070119.
• Exclude criteria: Please refer to ClinicalTrials.gov : NCT03070119.

Related Information

• Primary Sponsor: Biogen Japan Ltd.
• Secondary ID(s): NCT03070119,JapicCTI-205111