Clinical trial: MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) (NCT04579666)

Eligibility criteria:
Inclusion Criteria:

          -  At least 18 years of age

          -  Sporadic ALS diagnosed as definite, probable, or laboratory-supported probable as
             defined by the revised El Escorial criteria

          -  Slow vital capacity (SVC) ≥60% of the predicted value at screening

          -  Onset of ALS symptoms within 72 weeks (18 months) prior to screening

          -  Total ALSFRS-R score of ≥30 at screening

          -  Have vaccination within 5 years against Streptococcus pneumoniae, Neisseria
             meningitidis (types A, C, W, Y, and B), and Haemophilus influenzae (type B) or agree
             to receive vaccination

        Exclusion Criteria:

          -  Confirmed or suspected other causes of neuromuscular weakness

          -  Diagnosed with another neurodegenerative disease (examples include Parkinson's disease
             and Huntington's disease)

          -  Significant pulmonary disorder not attributed to ALS (eg, chronic obstructive
             pulmonary disease, pulmonary fibrosis, cystic fibrosis, pulmonary arterial
             hypertension)

          -  If taking riluzole, participant must be on a stable dose for 30 days prior to the
             start of the screening period. Use of riluzole is not required for participation.

          -  If taking edaravone, participant must be on a stable dose for 60 days prior to the
             start of the screening period. Use of edaravone is not required for participation.

          -  Participation in any other investigational drug trial or exposure to other
             investigational agent, device, or procedure within 30 days or within 5-half lives of
             the treatment (whichever is longer) prior to the start of the screening period or
             during study participation

          -  Use of any other complement inhibitor within 30 days or within 5-half lives of the
             treatment (whichever is longer) prior to the start of the screening period or during
             study participation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Contradiction