An exploratory clinical trial of CL2020 in patients with amyotrophic lateral sclerosis

JRCT ID: jRCT2063200047

Registered date:29/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Amyotrophic Lateral Sclerosis
• Date of first enrollment: 16/02/2021
• Target sample size: 5
• Study type: Interventional
• Intervention(s): CL2020 once every 4 weeks, total of 6 intravenous doses

Outcome(s)

• Primary Outcome: Safety and tolerability as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(1) Patients with new onset or within 2 years after onset at the start of screening
(2) Patients with 1 or 2 severity according to ALS severity criteria
(3) Subjects who can receive treatment on an outpatient basis

Exclude criteria

(1) Patients undergoing tracheostomy
(2) Patients who have worn non-invasive respiratory assist device
(3) Patients with% FVC of 80% or less
(4) Patients with chronic obstructive pulmonary disease (COPD)
(5) Patients with impaired respiratory function who complained of dyspnea at the end of screening(ALS FRS-R:10. Dyspnea, 11. Orthopnea, 12. Respiratory failure, any of those 3 items is 3 points or less)
(6) Patients using Edaravone injection within 4 weeks before the start of screening
(7) Patients who started taking Riluzole, or patients who changed or discontinued the dose after obtaining informed consent
(8) Patients with cognitive dysfunction (Alzheimer's disease and other dementia, Parkinson's disease, or other neurological disorders, etc.) that principal investigator/sub investigator has determined to affect their ability to participate in this trial or the evaluation of the clinical trial
(9) Patients with a history of surgery on the spine such as cervical spondylosis and herniated disc after the onset of ALS, or patients scheduled for surgery during the clinical trial period
(10) Patients who could not rule out the possibility of diseases symptoms that require differential diagnosis such as cervical spondylosis and multifocal motor neuropathy
(11) Patients with serious respiratory, cardiovascular or hepato-renal disorders
(12) Patients with complication of malignant tumor or history of it (however, patients who in
remission for 5 years could be included)
(13) Patients with collagen disease and related diseases
(14) Patients with severe diabetes mellitus (HbA1C >10%)
(15) Patients with active infectious disease requiring medical treatment(including HB antigen, HCV antibody, HIV antibody, HTLV-1 antibody, Syphilis)
(16) Patients who received high-dose intravenous immunoglobulin therapy within 8 weeks before the start of screening
(17) Patients who are taking systemic steroid hormone or immunosuppressant drugs
(18) Patients who have been treated with bone marrow transplantation or stem cell therapy
(19) Patients who are pregnant/possibly pregnant or breastfeeding
(20) Male or female patients who could not agree to birth control explained by principal investigator/sub investigator from completion of informed consent until completion of observation period
(21) Patients with history of allergy to aminoglycoside antibiotics including kanamycin
(22) Patients with history of allergy to human serum albumin formula or xenogeneic-derived protein (cow and swine)
(23) Patients who participated in other clinical trials within 12 weeks before completion of informed consent for the clinical trial
(24) Patients with or with a history of drug allergies or severe allergic diseases (anaphylactic shock, etc.)
(25) Patients with severe complications that principal investigator/sub investigator judged as inappropriate
(26) Patients who the principal investigator/sub investigator judged as inappropriate to participate

Related Information

• Primary Sponsor: Fukushima Tatsunobu