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 range
40 Years – 70 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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