Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT06008249
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
171 participants
INTERVENTIONAL
2021-08-09
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lithium carbonate
Lithium carbonate 400 mg capsules will be taken once daily, starting with one capsule (400 mg daily) initially titrated up to two or three capsules daily, depending on blood lithium levels. The target range for the lithium plasma level will be between ≥0.4 mmol/l and ≤ 0.8 mmol/l. Maximum duration is 24 months.
Lithium Carbonate 400 MG
Lithium carbonate vs placebo (2:1)
Placebo
Patients start with 1 capsule to be taken once daily, with subsequent sham dose adjustments made to patients on placebo to maintain blinding in clinical sites.
Lithium Carbonate 400 MG
Lithium carbonate vs placebo (2:1)
Interventions
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Lithium Carbonate 400 MG
Lithium carbonate vs placebo (2:1)
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of ALS according to the revised El Escorial criteria (possible, probable-laboratory supported, probable or definite).
3. Capable of providing informed consent and complying with trial procedures, including randomization to sub-studies.
4. TRICALS risk profile \> -6.0 and \< -2.0 \*\*
5. The use of riluzole will be permitted during the study. Subjects taking riluzole must be on a stable dose for at least 30 days prior to the baseline visit, or stopped taking riluzole at least 30 days prior to the baseline visit.
6. Women of childbearing potential\* must have a negative pregnancy test at baseline and be non-lactating.
7. Men must agree to practice contraception for the duration of the trial and for at least 3 months after last dose of study drug.
8. Men must not plan to father a child or to provide sperm for donation for the duration of the trial and 3 months after the last dose of study drug.
9. Women must not be able to become pregnant (e.g. post-menopausal\*\*\*, surgically sterile or using effective birth control methods) for the duration of the study. Effective contraceptives are defined as having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, including: abstinence, hormonal contraception, intrauterine device in place for ≥ 3 months Appendix 1). Women of childbearing potential must have a negative pregnancy test at baseline, and be non-lactating. Women who are pregnant or are actively seeking to become pregnant, and women of reproductive potential who are not using effective contraceptives are excluded.
Exclusion Criteria
* ALT (alanine transaminase) ≥ 5 times upper limit of normal (ULN)
* AST (aspartate aminotransferase) ≥ 3 times ULN
* Bilirubin ≥ 1.5 times ULN
* Estimated glomerular filtration rate (eGFR) \< 50 mL / min / 1.73 m2 based on Cystatin C, if not available eGFR can also be calculated based on creatinine clearance.
* Platelet concentration of \< 100 x109 per L
* Absolute neutrophil count of \< 1x109 per L
* Haemoglobin \< 100 g/L (\<6.2 mmol/L)
* Amylase \& lipase ≥ 2 times ULN (suspected pancreatitis)
* 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 ascites.
3. Participation in any other investigational drug trial or using investigational drug (within 30 days prior to screening).
4. Hypothyroidism unresponsive to thyroid hormone supplementation.
5. Subjects using non-invasive ventilation (NIV, ≥22 h per day) or having a tracheostomy.
6. Subjects taking edaravone within 30 days prior to screening. Edaravone is approved by the FDA, but remains an investigational product in Europe and Australia.
7. Clinically significant history of unstable or severe cardiac (e.g. congestive heart failure, coronary insufficiency and arrhythmias), oncological, hepatic or renal disease, neuromuscular diseases, significant pulmonary disorder or other medically significant illness.
8. Drug or alcohol abuse.
9. 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 Psychiatrist.
10. Presence of frontotemporal dementia which prevents informed consent.
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 placebo.
3. 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 not.
4. Addison disease.
5. Patients with the following co-medication: antipsychotics, digoxin and calcium antagonists, carbamazepine, methyldopa, verapamil and diltiazem.
6. Brugada Syndrome or family history of Brugada Syndrome.
7. Plasma sodium \<120 mmol/L
18 Years
ALL
No
Sponsors
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Fight MND
UNKNOWN
Research Foundation Flanders
OTHER
MNDA
UNKNOWN
Thierry Latran Foundation
UNKNOWN
Ulla-Carin Lindquist Foundation
UNKNOWN
Luzon Foundation
UNKNOWN
Alan Davidson Foundation
UNKNOWN
My name'5 Doddie Foundation
UNKNOWN
Stichting ALS Nederland
UNKNOWN
Stichting TRICALS Foundation
OTHER
Responsible Party
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Principal Investigators
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Leonard Van den Berg, MD
Role: STUDY_CHAIR
TRICALS Foundation
Locations
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Flinders Medical Centre
Adelaide, , Australia
Royal Brisbane and Women's Hospital
Brisbane, , Australia
Calvary Health Care Bethlehem
Parkdale, , Australia
Perron Institute
Perth, , Australia
The University of Sydney (Royal prince Alfred hospital)
Sydney, , Australia
Concord hospital Sydney
Sydney, , Australia
University Hospital Leuven
Leuven, , Belgium
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Bellvitge University Hospital
Barcelona, , Spain
Karolinska University Hospital
Stockholm, , Sweden
King's College Hospital
London, , United Kingdom
University College London Hospital NHS
London, , United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MAGNET
Identifier Type: -
Identifier Source: org_study_id
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