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Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis (ALS) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis (ALS)

A Multi-arm, Adaptive, Group-sequential Trial NETwork to Evaluate Drug Efficacy in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT06008249•Stichting TRICALS Foundation

View on ClinicalTrials.gov

Summary

The objective of this phase III, placebo-controlled platform study is to investigate the efficacy of drugs for patients with ALS (Amyotrophic lateral sclerosis).

Detailed Description

This study uses an innovative multi-arm, adaptive trial design to investigate the efficacy of multiple treatments simultaneously. Currently one study-arm is active, investigating the efficacy and safety of lithium carbonate versus placebo in patients with ALS. Only patients with a specific UNC13A genotype (approximately 1 in 6 ALS patients) are eligible to participate.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥ 18 years at the time of screening.
•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

•1. Laboratory Criteria at baseline:
•* 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)
+16 more criteria

Locations (13)

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

Key Dates

Start Date

August 9, 2021

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

June 11, 2025

Enrollment

171

ESTIMATED participants

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Lithium Carbonate 400 MG

DRUG

Contacts

Roel Vink, PhD

CONTACT

+31 6 50177777 magnet@tricals.org

Leonard van den Berg, MD

CONTACT

0887557939 L.H.vandenBerg@umcutrecht.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis (ALS)

Inclusion Criteria

Exclusion Criteria

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Intermuscular Coherence as a Biomarker for ALS

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

UPenn Observational Research Repository on Neurodegenerative Disease

Control Cohort CTRL COH

ASSESS ALL ALS Study