Clinical trial: Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (NCT01753076)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with diagnosis of familial or sporadic ALS

          -  Onset of muscle weakness no more than 30 months before screening visit.

          -  Slow Vital Capacity (SVC) of at least 65% predicted for gender, age, ethnicity and
             height at Screening.

          -  If on riluzole, the dose must have been stable for at least 28 days prior to Baseline
             visit.

          -  Age 18 - 80 years inclusive.

          -  Female subjects may participate if they are of non-child-bearing potential or if they
             are of child-bearing potential they must agree to use the approved contraceptive
             methods

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2x upper limit
             of normal (ULN); alkaline phosphatase and bilirubin <=1.5xULN.

          -  QTc (both QTcB and QTcF) <450 milliseconds (msec) or <480 msec for subjects with
             Bundle Branch Block at Screening and Baseline (average from triplicate ECGs).

        Exclusion Criteria:

          -  Patients with other neuromuscular disorders (including a history of polio) which in
             the opinion of the investigator could have contributed to the muscular atrophy or
             weakness caused by ALS

          -  Patients with primary lateral sclerosis, monomelic ALS, ALS Parkinsonism dementia
             complex.

          -  Patients requiring non-invasive or mechanical ventilation (non-invasive ventilation
             for sleep apnoea is allowed subject to discussion with Medical Monitor)

          -  Patients on diaphragmatic pacing.

          -  Presence of any of the following clinical conditions: Drug abuse or alcoholism,
             uncontrolled hypertension, active major infectious disease, unstable psychiatric
             illness within 90 days of the Screening visit

          -  Subjects, who in the investigator's judgement, pose a significant suicide risk. -
             Current or chronic history of liver disease, known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones), positive
             Hepatitis B surface antigen or Hepatitis C antibody test.

          -  Subjects who have participated in a clinical trial involving receipt of a
             biopharmaceutical product within 6 months prior to the first dosing day.

          -  Exposure to non-biological experimental agents 1 month or 5 half-lives prior to
             Baseline visit (whichever is longer).

          -  History of sensitivity to ozanezumab, or components thereof, or a history of other
             allergies that, in the opinion of the investigator, contraindicates participation in
             the study.
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.
Subject must be at most 80 Years

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? Entailment