Based in Mexico City, Instituto Nacional de Neurologia y Neurocirugia are now enrolling people living with ALS for a phase 2 study investigating the effect of dual treatment with lithium and valproate on ALS. Both lithium and valproate are thought to have neuroprotective properties and are used for the treatment of various mental illnesses, and in some cases, as a therapy for epilepsy. There have been a number of inconclusive studies in the past using one or both of these drugs for the treatment of ALS.
Researchers aim to recruit 40 people living with ALS in 
this randomized, placebo-controlled trial. Treatment will consist 600mg of magnesium valproate and 600mg of lithium carbonate per day administered orally for 20 months. Half of the participants will receive the treatment and the remainder will be given the placebo. There is currently one location open for enrollment at Instituto Nacional de Neurologia Y Neurocirugia. Efficacy of the treatment will be judged primarily on changes in their ALS Functional Rating Scale (ALSFRS-R) from baseline, every 2 months for 20 months. Changes to The ALS Assessment Questionnaire (ALSAQ-5) will also be taken into account. The ALSAQ-5 is a similar method of tracking disease progression as ALSFRS-R but is patient answered, rather than physician generated. Slow or forced vital capacity will not be taken into account as an outcome measure in this study.
To qualify for enrollment in this trial, people living with ALS must be between the ages of 40-70 years. Younger participants may be permitted at the researcher’s discretion. Participants should have a vital capacity of at least 60% of the predicted value for gender, age and height and should have experienced onset of symptoms for 6-18 months. Those taking Riluzole are permitted to take part but must be taking a steady dose before and during the entire study. The sponsor has provided a complete list of inclusion and exclusion criteria on clinicaltrials.gov.
A full description of this clinical trial including contact information can be found online here. Updates on site enrollment status and other changes to the study are monitored by ALS TDI and sent monthly via email to those subscribed to the clinical trial mailing list.
Helpful links:
https://clinicaltrials.gov/ct2/show/NCT03204500
https://www.als.net/als-research/clinical-trials/315/
https://www.patientslikeme.com/treatments/show/26120-magnesium-valproate-side-effects-and-efficacy