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.
Name: Active treatment with dual therapy
Description: To evaluate the effect of VPA+Li on progression of ALS by measuring functionnal changes from baseline in ALSFRS-R.Measure: Changes in ALSFRS-R Time: Every 2 months for 20 months
Description: Changes from baseline in ALSAQ-5, a brief self-administered quality of life scale.Measure: Changes in score in ALSAQ-5 Time: Baseline, Month 10, Month 20
Description: DTI biomarkers in corticospinal tract are measured in 6 regions bilaterallyMeasure: Changes from baseline in FA (fractional anisotropy) Time: Baseline and month18
There is one SNP
In the same year, two Chinese studies showed a synergistic neuroprotective effect of valproate administered with lithium in neuronal cultures and in G93A ALS transgenic models. --- G93A ---