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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Leonard
van den Berg
+31 (0)6 501 77777
magnet@tricals.org
Prof
Ammar
Al-Chalabi
-
ammar.al-chalabi@kcl.ac.uk
Prof
Leonard
van den Berg
+31 (0)6 501 77777
magnet@tricals.org
Amyotrophic lateral sclerosis (ALS)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Amyotrophic lateral sclerosis (ALS) is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. The aim of this study is to simultaneously investigate the effectiveness and safety of multiple drugs for ALS. We do this by using so-called 'study arms'. Each study arm investigates the effectiveness and safety of one drug or a combination of drugs. Once it is clear which arm of the study they are participating in, participants will be assigned a drug or placebo by drawing lots. A placebo is a substance without an active substance, a 'fake substance'. Currently one arm is active that investigates the effect of lithium carbonate vs placebo in ALS. Lithium is a substance currently registered for use in bipolar disorders. This is a psychiatric disease that causes severe mood swings. Lithium affects multiple biological mechanisms involved in ALS. Previous research has shown that the drug is not effective in all patients with ALS, but may be beneficial in patients with a variation in the UNC13A gene (1 in 6 patients has this variation). Lithium is not currently being prescribed for ALS outside of this study.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
For all subjects: 1. Safety Laboratory Criteria at baseline:1.1. ALT ≥5 times upper limit of normal (ULN)1.2. AST ≥3 times ULN1.3. Bilirubin ≥1.5 times ULN1.4. Creatinine clearance <50 ml/min (Cockroft-Gault) based on Cystatin C1.5. Platelet concentration of < 100 x109 per L1.6. Absolute neutrophil count of < 1x109 per Lo Haemoglobin <100 g/L (<6.2 mmol/L)1.7. Amylase & lipase ≥2 times ULN (suspected pancreatitis)1.8. Lactate ≥2 times ULN (suspected lactate acidosis)2. Moderate to severe hepatic impairment according to Child-Pugh classification (Class B or higher; score ≥ 7). Child-Pugh classification is based on bilirubin, albumin, International Normalized Ratio (INR) and presence of encephalopathy or ascites3. Participation in any other investigational drug trial or using investigational drug (within 30 days prior to screening)4. Hypothyroidism unresponsive to thyroid hormone supplementation5. Subjects using non-invasive ventilation (NIV, ≥22 h per day) or having a tracheostomy6. Subjects taking edaravone within 30 days prior to screening. Edaravone is approved by the FDA, but remains an investigational product in Europe and Australia7. Clinically significant history of unstable or severe cardiac (e.g. congestive heart failure, coronary insufficiency and arrhythmias), oncological, hepatic or renal disease, neuromusculair diseases, significant pulmonary disorder or other medically significant illness8. Drug or alcohol abuse9. Unstable psychiatric illness defined as psychosis or untreated major depression within 90 days of the screening visit. This exclusion criterion is based on a prior psychiatric diagnosis that is unstable as determined by the subject’s treating psychiatrist10. Presence of frontotemporal dementia which prevents informed consent
For lithium carbonate:1. Patients heterozygous or homozygous for the A-allele of rs12608932 (UNC13A)2. Known allergy or hypersensitivity to lithium, or its excipients, or to the components of the placebo3. Brain injury with posttraumatic epilepsy or neurologic deficit, excluding a concussion in the medical history. Brain infarction is an exclusion criterion, a transient ischemic attack is not4. Addison disease5. Patients with the following co-medication: antipsychotics, digoxin and calcium antagonists, carbamazepine, methyldopa, verapamil and diltiazem6. Brugada Syndrome or family history of Brugada Syndrome7. Plasma sodium <120 mmol/L
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Leonard
van den Berg
+31 (0)6 501 77777
magnet@tricals.org
Prof
Leonard
van den Berg
+31 (0)6 501 77777
magnet@tricals.org
Prof
Ammar
Al-Chalabi
-
ammar.al-chalabi@kcl.ac.uk
The study is sponsored by Stichting TRICALS Foundation and funded by Stichting TRICALS Foundation.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 53777
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
