Clinical trial: 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS) (NCT03843710)

Eligibility criteria:
Inclusion Criteria:

          1. Able to understand and give written informed consent.

          2. Male or female patients aged 35 years or greater (inclusive) and less than 75 years of
             age at the time of ALS diagnosis.

          3. Patients with a confirmed ALS diagnosis: "definite ALS" or "probable ALS" or
             "possible" diagnostic criteria per the revised El Escorial Criteria as determined by a
             neurologist subspecializing in ALS (e.g., the Principal Investigator by study site).

          4. Stable background therapy (e.g., stable dosing of riluzole within the prior 6-weeks)
             per Investigator discretion.

          5. At the time of Screening disease duration less than or equal to 24-months from symptom
             onset OR within 12-moths of a confirmed ALS diagnosis.

          6. Forced vital capacity (FVC) >/= 60% of predicted value as adjusted for gender, height,
             and age at the Screening Visit.

          7. Patients who are ambulatory (e.g., normal ambulation, early ambulation difficulties,
             or walks with assistance) on the ALSFRS-R scale.

        Exclusion Criteria:

          1. At Screening patients who utilize, or in the Investigator's judgment will be
             imminently dependent upon during the course of this study:

               1. Non-invasive ventilation

               2. Gastrostomy (e.g., use of percutaneous endoscopic gastrostomy tube)

               3. Use of wheel chair

          2. Patient who have previously undergone tracheostomy.

          3. Patient with a history of significant other major medical condition based on the
             Investigator's judgment.

          4. Based on the investigator's judgment, patients who may have difficulty complying with
             the protocol and/or study procedures.

          5. Patient with clinically significant abnormalities in hematology, blood chemistry, ECG,
             or physical examination not resolved by the Baseline visit which according to
             Investigator can interfere with study participation.

          6. Patient participating in any other investigational drug trial or using investigational
             drug (within 12 weeks prior to screening and thereafter)

          7. Females who are pregnant or nursing or who plan to get pregnant during the course of
             this clinical trial or within 6 months of the end of this trial.

          8. Positive screen for drugs of abuse or known alcohol abuse.

          9. Women of child-bearing potential, or men, who are unwilling or unable to use accepted
             methods of birth control during the study or for 6 months following completion of
             study participation.

         10. Women with a positive pregnancy test, are lactating, or are planning to become
             pregnant during the study.

         11. Patients with implanted metal objects in their body that may be affected by an MRI
             procedure.

         12. Patients who are claustrophobic or otherwise unlikely to be able to complete the MRI
             scanning procedures.

         13. Patients with a history of gold allergy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 75 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