NCT06008249

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (estimated)
• Sponsor: Stichting TRICALS Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Lithium Carbonate 400 MG	Lithium carbonate vs placebo (2:1)

Timeline

• Start date: 2021-08-09
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-08-23
• Last updated: 2025-06-11

Locations

13 sites across 6 countries: Australia, Belgium, Netherlands, Spain, Sweden, United Kingdom