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

NCT03204500 Phase 2 COMPLETED

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.

Details

Lead sponsor	El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Phase	Phase 2
Status	COMPLETED
Enrolment	43
Start date	2016-05
Completion	2019-08

Conditions

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis, Sporadic

Interventions

• Active treatment with dual therapy
• Placebos

Primary outcomes

• Changes in ALSFRS-R — Every 2 months for 20 months
  To evaluate the effect of VPA+Li on progression of ALS by measuring functionnal changes from baseline in ALSFRS-R.

Countries

Mexico