Dual Treatment With Lithium and Valproate in ALS.

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study in 40 subjects with definite ALS to evaluate the efficacy of valproate and lithium carbonate. After a random assignation of the dual treatment vs. placebo, a follow-up of 20 months will allow to know the clinical and functional evolution so as the status of biomarkers under each treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
• Treatments: Lithium Carbonate; Valproic Acid

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.