RecruitingPhase 3NCT06008249

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)


Sponsor

Stichting TRICALS Foundation

Enrollment

171 participants

Start Date

Aug 9, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a platform trial testing multiple experimental drugs for people with ALS (also known as Lou Gehrig's disease), a condition that gradually weakens the muscles. A platform trial means different drugs can be tested at the same time within the same study framework. **You may be eligible if...** - You are 18 or older - You have been diagnosed with ALS based on established clinical criteria - Your disease is at a moderate progression level (as measured by a standard ALS risk score) - You are willing and able to use contraception during and after the trial if you can have children - You are currently taking riluzole (a common ALS medication) at a stable dose, or have stopped it at least 30 days ago **You may NOT be eligible if...** - Your ALS is very mild or very advanced (outside the specified risk profile) - You are pregnant or planning to become pregnant - You are currently breastfeeding - You are unable to complete study visits and procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLithium Carbonate 400 MG

Lithium carbonate vs placebo (2:1)


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

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06008249


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