Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03693781
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2018-09-30
Brief Title:
Colchicine for Amyotrophic Lateral Sclerosis
Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Organization:
Azienda Ospedaliero-Universitaria di Modena
Study Overview
Official Title:
Colchicine for Amyotrophic Lateral Sclerosis a Phase II Randomized Double Blind Placebo Controlled Multicenter Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-02
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:
Co-ALS
Brief Summary:
The study evaluates the effects of two different Colchicine doses 001mgkgday or 0005 mgkgday compared to placebo in Amyotrophic Lateral Sclerosis ALS patients Disease progression as defined by changes in ALSFRS-r is the primary outcome measure Other measures of clinical progression and survival together with safety and tolerability of Colchicine in ALS patients will be assessed
Detailed Description:
Recent evidence supports the disruption of the ubiquitin-proteasome-system and autophagy as central events in ALS ALS is characterized by the presence of misfolded proteins prone to oligomerize into aggregates which exert a toxic effect by affecting several intracellular functions Heat shock protein B8 HSPB8 recognizes and promotes the autophagy-mediated removal of misfolded mutant SOD1 and TDP-43 fragments from ALS motor neurons MNs Moreover HSPB8-BAG3-HSP70 maintains the so called granulostasis a surveillance mechanism that avoids the conversion of dynamic stress granules SGs into aggregation-prone assemblies which are a hallmark of ALS
Colchicine enhances the expression of HSPB8 and of several autophagy players while blocking TDP-43 accumulation in neurons Moreover given the cross-talk between infalmmation and autophagy the well-known antinflammatory action of Cochicine may contribute to cell homeostasis
Based on these premises this is a phase II randomized double-blind placebo-controlled multicenter 9 MND Centres in Italy 2 centres in Milan Pavia Turin Modena Padua Rome Naples Bari clinical trial to test efficacy of Colchicine in ALS
Colchicine enhances the expression of HSPB8 and of several autophagy players while blocking TDP-43 accumulation in neurons Moreover given the cross-talk between infalmmation and autophagy the well-known antinflammatory action of Cochicine may contribute to cell homeostasis
Based on these premises this is a phase II randomized double-blind placebo-controlled multicenter 9 MND Centres in Italy 2 centres in Milan Pavia Turin Modena Padua Rome Naples Bari clinical trial to test efficacy of Colchicine in ALS
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?:
False
Is an FDA AA801 Violation?:
None