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Dual Treatment With Lithium and Valproate in ALS.

NCT03204500 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-08-10

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

Active treatment with dual therapy

Blue pills ( 200 mg of magnesium valproate ) and white pills ( 300 mg of lithium carbonate) are administered orally with meals.

DRUG

Placebos

Administered orally under the same conditions

Sponsors & Collaborators

  • El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

    lead OTHER

Principal Investigators

  • MARIE CATHERINE BOLL, MD,PhD. · 525556063822

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-04-30
Completion
2019-08-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204500 on ClinicalTrials.gov