MERIDIAN

JRCT ID: jRCT2031230170

Registered date:25/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Sporadic ALS
• Date of first enrollment: 02/08/2021
• Target sample size: 40
• Countries of recruitment: US,Japan,Poland,Japan,Italy,Japan,Germany,Japan,Czechia,Japan,Blgium,Japan,Australia,Japan,Netherland,Japan,Spain,Japan,Ukraine,Japan,France,Japan,UK,Japan,Argentina,Japan,Brazil,Japan,Ireland,Japan
• Study type: Other
• Intervention(s): Pegcetacoplan, 1080 mg twice per week, SC

Outcome(s)

• Primary Outcome: CAFS rank score (joint-rank score) at Week 52

Key inclusion & exclusion criteria

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

Include criteria

1. Sporadic ALS diagnosed as definite
2. At least 18 years of age
3. Show vital capacity >=60% of the predicted value at screening
4. Onset of ALS symptoms within 72 weeks prior to screening
5. Total ALSFRS-R score of >=30 at screening
6. Women of childbearing potential must have a negative pregnancy test and must agree to use protocol defined methods of contraception
7. Males must agree to use protocol defined methods of contraception
8. Have vaccination against Streptococcus pneumoniae, Neisseria meningitidis (types A, C,
W, Y, and B), and Haemophilus influenzae (type B) either within 5 years prior to Baseline
Visit 2b, or agree to receive vaccination at least 7 days prior to Baseline Visit 2b.
9. Willing and able to give informed consent and comply with study procedure and
assessments (including at-home assessments)

Exclude criteria

1. Confirmed or suspected other causes of neuromuscular weakness
2. Diagnosis of another neurodegenerative disease(s)
3. Subject with significant cognitive impairment, clinical dementia, or psychiatric illness that in the opinion of the investigator may increase subject's risk by participating in the study or confound the outcome of the study
4. Subject with significant disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function (eg. chronic obstructive pulmonary disease, pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension)
5. Current use or anticipated need, in the opinion of the investigator, of a diaphragm pacing system during the randomized treatment period
6. Riluzole initiation or change in dose is required
7. Edaravone initiation or change in dose is required
8. Positive response to Item 4 or 5 of the Columbia Suicide Severity Rating Scale
9. History or active malignant disease
10. Received organ transplant

Related Information

• Primary Sponsor: Kreisl Chuck
• Secondary ID(s): NCT04579666