Clinical trial: Dual Treatment With Lithium and Valproate in ALS. (NCT03204500)

Eligibility criteria:
Inclusion Criteria:

          -  patients aged 40 to 70 years

          -  of both genders

          -  female patients who are either postmenopausal for at least 24 months or who are able
             to practice 2 methods of contraception.

          -  Clinical diagnosis of definite ALS supported by neurophysiological studies, according
             to El Escorial reviewed criteria and Awaji criteria.

          -  Sporadic ALS, a priori.

          -  Onset of weakness for 1 year ± 6 months

          -  Vital capacity of at least 60 % of the predicted value

          -  Other treatment (with riluzole or not) at fixed dosis 2 months before and during all
             the clinical trial.

          -  Patients who are willing to give informed consent

          -  Without gastrostomy

          -  Without jejunostomy

          -  Without traqueostomy

        Exclusion Criteria:

          -  Age less than 25 years**

          -  Patients with uncontrolled diabetes

          -  Patient with heart failure

          -  Patient with respiratory vital capacity < 60%

          -  Hepatic failure

          -  Dysthyroidism

          -  Do not give or sign informed consent

          -  Women in lactation, pregnancy or possibility of pregnancy

          -  Patients with significant sensory abnormalities and uncompensated medical illnesses

          -  Laboratory abnormalities consistent with clinically significant cardiovascular,
             respiratory, haematological, metabolic, hepatic and renal disease.

          -  Patients with gastrostomy

          -  With jejunostomy

          -  With nasogastric tube

          -  Tracheotomy and invasive ventilation

          -  Treatment with investigational drug within 3 months prior to screening

               -  Patients aged 26 to 39 years can be included at the discretion of medical
                  researchers.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 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