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Report for Clinical Trial NCT03204500

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Clinical Trial, Double Blind, Placebo-controlled of Lithium and Valproate in Amyotrophic Lateral Sclerosis.

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.

NCT03204500 Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis, Sporadic
MeSH:Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis

2 Interventions

Name: Active treatment with dual therapy

Description: Blue pills ( 200 mg of magnesium valproate ) and white pills ( 300 mg of lithium carbonate) are administered orally with meals.
Type: Combination Product
Group Labels: 1

Active treatment with dual therapy

Name: Placebos

Description: Administered orally under the same conditions
Type: Drug
Group Labels: 1


Primary Outcomes

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

Secondary Outcomes

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 bilaterally

Measure: Changes from baseline in FA (fractional anisotropy)

Time: Baseline and month18

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 G93A

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 ---

HPO Nodes