Clinical trial: Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis (NCT04518540)

Eligibility criteria:
Inclusion Criteria:

          1. Age range from 20 to 75 (including 20 and 75 years old), regardless of ethnic group or
             gender;

          2. The subjects should meet the diagnostic criteria for ALS by El Escorial revised
             criteria: "Definite ALS", "Probable ALS" and "Probable, laboratory-supported ALS".

          3. ALS Functional Rating Scale-Revised (ALSFRS-R 12 items) each item score ≥2 points;

          4. The onset (the symptoms of limbs weakness, muscle atrophy or bulbar involvement ) of
             the disease is less than 2 years

          5. Baseline breath function: Forced Vital Capacity≥70% .

          6. Disease Progression Rate FS=(48- ALSFRS-R at "time of diagnosis")/duration from onset
             to diagnosis (month), progression rate FS≤1;

        Exclusion Criteria:

          1. Combined with one of cerebrovascular disease, spinal cord disease, spinal muscular
             atrophy, juvenile myoatrophy of distal upper extremity, multifocal motor neuropathy,
             Kennedy disease, epilepsy, etc;

          2. Severe renal insufficiency: creatinine clearance rate <30 mL/min (Cockcroft-Gault
             formula, urea nitrogen and (or) blood creatinine> 1.5 times the upper limit of normal,
             or other known severe renal insufficiency diseases;

          3. Severe liver damage: ALT, AST> 3 times the upper limit of normal, or other known liver
             diseases such as acute and chronic hepatitis, cirrhosis, etc.;

          4. Obvious tachycardia or bradycardia; patients with acute myocardial infarction or
             interventional therapy in the past 6 months (patients with grade III-IV according to
             NYHA classification);

          5. Combined with malignant tumor, blood, digestion or other serious diseases;

          6. Female patients during pregnancy and lactation;

          7. Participated in other clinical trials within 30 days before randomization, or are
             participating in other clinical trials;
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 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? 1