ALS biomarker research

JRCT ID: jRCTs051180229

Registered date:30/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: amyotrophic lateral sclerosis (ALS)
• Date of first enrollment: 19/04/2019
• Target sample size: 49
• Study type: Interventional
• Intervention(s): collection of cerebrospinal fluid

Outcome(s)

Primary Outcome

Alteration of blood biomerkers including SOD1, TDP-43, Src, c-Abl, etc.
Alteration of CSF biomerkers including neurofilament L, phosphorylated neurofilament H, SOD1, TDP-43, etc.
Alteration of urine biomerkers including p75, etc.
Plasma concentration of bosutinib (through value)
CSF concentration of bosutinib (through value)
Evaluation of biomerkers using iPS cells

• Secondary Outcome: N/A

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both
• Include criteria: Those who agree to attend the current clinical study among ALS patients joining an accompanying clinical trial "Phase 1/2 Dose Escalation Study of Bostinib in Patients with Amyotrophic Lateral Sclerosis (ALS)"
• Exclude criteria: N/A

Related Information

• Primary Sponsor: Inoue Haruhisa
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development