Dual Treatment With Lithium and Valproate in ALS. (NCT03204500) | Clinical Trial Compass
CompletedPhase 2
Dual Treatment With Lithium and Valproate in ALS.
Mexico43 participantsStarted 2016-05
Plain-language 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.
Who can participate
Age range40 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients aged 40 to 70 years
* of both genders
* female patients who are either postmenopausal for at least 24 months or who are able to practice 2 methods of contraception.
* Clinical diagnosis of definite ALS supported by neurophysiological studies, according to El Escorial reviewed criteria and Awaji criteria.
* Sporadic ALS, a priori.
* Onset of weakness for 1 year ± 6 months
* Vital capacity of at least 60 % of the predicted value
* Other treatment (with riluzole or not) at fixed dosis 2 months before and during all the clinical trial.
* Patients who are willing to give informed consent
* Without gastrostomy
* Without jejunostomy
* Without traqueostomy
Exclusion Criteria:
* Age less than 25 years\*\*
* Patients with uncontrolled diabetes
* Patient with heart failure
* Patient with respiratory vital capacity \< 60%
* Hepatic failure
* Dysthyroidism
* Do not give or sign informed consent
* Women in lactation, pregnancy or possibility of pregnancy
* Patients with significant sensory abnormalities and uncompensated medical illnesses
* Laboratory abnormalities consistent with clinically significant cardiovascular, respiratory, haematological, metabolic, hepatic and renal disease.
* Patients with gastrostomy
* With jejunostomy
* With nasogastric tube
* Tracheotomy and invasive ventilation
* Treatment with investigational drug within 3 months prior to screening
* Patients aged 26 to 39 years can be included at the discretion of medical researchers.
What they're measuring
1
Changes in ALSFRS-R
Timeframe: Every 2 months for 20 months
Trial details
NCT IDNCT03204500
SponsorEl Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez