SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03204500

Developed by Shray Alag, 2019.
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: Sclerosis Motor Neuron Disease Amyotrophic Lateral 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

Active treatment with dual therapy

Name: Placebos

Description: Administered orally under the same conditions

Type: Drug

placebos


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

SNPs


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


HPO:
Abnormal anterior horn cell morphology
Genes 12
CPLANE1 VRK1 IGHMBP2 UBA1 TFG SOD1 SETX CEP126 ASAH1 GLE1 SMN1 ATXN3
Amyotrophic lateral sclerosis
Genes 44
VAPB TREM2 CCNF PON1 PON2 PON3 NEFH DAO PPARGC1A TARDBP NEK1 ALS2 SPG11 ERBB4 CHCHD10 TAF15 OPTN SETX FUS UBQLN2 ANG PSEN1 C9ORF72 PFN1 DCTN1 ATXN2 FIG4 SIGMAR1 MAPT HNRNPA1 GLE1 HNRNPA2B1 TUBA4A SQSTM1 UNC13A CFAP410 MATR3 TBK1 ANXA11 SOD1 VCP CHMP2B EPHA4 PRPH