Clinical trial: The Effect of RNS60 on ALS Biomarkers (NCT03456882)

Eligibility criteria:
Inclusion Criteria:

          1. Age 18 through 80 years inclusive;

          2. Geographically accessible to the site and able to come to the site once a week for 24
             weeks;

          3. Definite, probable, probable laboratory supported ALS diagnosis according to the
             revised El Escorial criteria; 4) Disease duration 6 to 24 months from symptom onset;

        5) Self sufficiency: Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for
        swallowing, cutting food and handling utensils, and walking); 6) Satisfactory respiratory
        function (FVC ≥80% of predicted); 7) Documented progression of symptoms in the last three
        months, as measured by the ALSFRS-R scale; 8) Ability to understand and comply with the
        study requirements and to give written informed consent personally or via a legally
        authorized representative; 9) Treatment with riluzole 50 mg twice/day for at least 1 month
        prior to screening visit.

        Self sufficiency: this term reflect independence in daily living activities. It is an
        intuitive parameter to indicate preservation of key functional activities, and - not least
        - it has shown to be a valid and reliable measure

        Exclusion Criteria:

          1. History of HIV, clinically significant chronic hepatitis, antecedent polio infection,
             or other active infection;

          2. Motor neuron disease (MND) other than ALS;

          3. Involvement of systems other than motor possibly determining a functional impairment
             (as measured by the end-points) for the entire duration of the study;

          4. Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with
             impact on survival or functional disability in the next 12 months;

          5. Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of
             normal;

          6. Poor compliance with previous treatments;

          7. Other experimental treatments in the preceding 3 months;

          8. Women who are lactating or able to become pregnant (e.g. who are not post menopausal,
             surgically sterile, or using inadequate birth control) and men unable to practice
             contraception for the duration of the treatment and 3 months after its completion;

          9. Unwillingness or inability to take riluzole; 10) Poor capability to use an inhalation
             device;

         10. Abnormal liver function defined as AST and/or ALT > 3 times the upper limit of the
             normal.
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