Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008249
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-08-14
Brief Title:
Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis ALS
Sponsor:
Stichting TRICALS Foundation
Organization:
Stichting TRICALS Foundation
Study Overview
Official Title:
A Multi-arm Adaptive Group-sequential Trial NETwork to Evaluate Drug Efficacy in Patients With Amyotrophic Lateral Sclerosis ALS
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None