PSO17CSF Study in Motor Neuron Disease

JRCT ID: jRCT2011220046

Registered date:25/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: motor neuron disease
• Date of first enrollment: 08/12/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Intrathecal injection of 10mL or 15mL or 20mL of PSO17CSF

Outcome(s)

• Primary Outcome: safety

Secondary Outcome

change in MRI signal intensity.
safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Over 18 years old when informed consent is obtained.
(2) Patients with motor neuron disease.
(3) The patients scheduled for lumbar puncture.
(4) Written informed consent is obtained after sufficient explanation and full understanding.

Exclude criteria

(1) Contraindication for MRI such as metallic implant, tattoo in the body.
(2) Severe lumbar canal stenosis.
(3) Currently enrolled in another research.
(4) Previous history of drug allergy
(5) Serious disease of liver, kidney, heart, etc.
(6) Current or planned pregnancy.
(7) The patients with lesions on MRI scan in the previous observation period (except when the investigator determines that there is no problem with participation in the clinical trial).
(8) Any other reason judged by a clinical trial doctor that renders the candidate unsuitable for this clinical trial.

Related Information

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