Ignite Creation Date:
2024-05-06 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03387670
Status:
COMPLETED
Last Update Posted:
2022-07-07
First Post:
2017-11-28
Brief Title:
Multiple Sclerosis-Simvastatin Trial 2
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
A Phase 3 Randomised Double Blind Clinical Trial Investigating the Effectiveness of Repurposed Simvastatin Compared to Placebo in Secondary Progressive Multiple Sclerosis in Slowing the Progression of Disability
Status:
COMPLETED
Status Verified Date:
2024-09
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:
MS-STAT2
Brief Summary:
Multiple Sclerosis MS is a progressive neurological disorder of the brain and spinal cord It affects approximately 120000 people in the United Kingdom and 25 million people globally Most people with MS experience two stages of the disease
Early MS - Relapsing-Remitting MS RRMS which is partially reversible and Late MS - Secondary Progressive MS SPMS which affects the majority of patients usually after 10 to 15 years after diagnosis
SPMS results from progressive neuronal degeneration that causes accumulating and irreversible disability affecting walking balance manual function vision cognition pain control bladder and bowel function The pathological process driving the accrual of disability in SPMS is not known at present
Immunomodulatory anti-inflammatory disease modifying therapies DMTs are increasingly effective in reducing relapse frequency in RRMS however they have been unsuccessful in slowing disease progression in SPMS This is the overwhelming conclusion from an analysis of 18 phase 3 trials n8500 of which 70 of the population had SPMS all performed in the last 25 years
In an earlier study Multiple Sclerosis-Simvastatin 1 MS-STAT1 140 people with SPMS were randomly assigned to receive either placebo or simvastatin for a period of two years The investigators found that the rate of brain atrophy loss of neurons - brain shrinkage as measured by magnetic resonance imaging MRI was reduced in patients receiving simvastatin compared to those taking placebo
Several other long term studies have also reported that there might be a relationship between the rate of brain atrophy and the degree of impairment The study is designed to test the effectiveness of repurposed simvastatin 80mg in a phase 3 double blind randomised placebo controlled trial 11 in patients with secondary progressive MS SPMS to determine if the rate of disability progression can be slowed over a 3 to 45 year period
The results generated from this trial may help to improve the treatment options of people with MS In addition taking part in this trial will mean regular review by an experienced neurologist regardless of the drug that patients are randomly allocated to receive
Early MS - Relapsing-Remitting MS RRMS which is partially reversible and Late MS - Secondary Progressive MS SPMS which affects the majority of patients usually after 10 to 15 years after diagnosis
SPMS results from progressive neuronal degeneration that causes accumulating and irreversible disability affecting walking balance manual function vision cognition pain control bladder and bowel function The pathological process driving the accrual of disability in SPMS is not known at present
Immunomodulatory anti-inflammatory disease modifying therapies DMTs are increasingly effective in reducing relapse frequency in RRMS however they have been unsuccessful in slowing disease progression in SPMS This is the overwhelming conclusion from an analysis of 18 phase 3 trials n8500 of which 70 of the population had SPMS all performed in the last 25 years
In an earlier study Multiple Sclerosis-Simvastatin 1 MS-STAT1 140 people with SPMS were randomly assigned to receive either placebo or simvastatin for a period of two years The investigators found that the rate of brain atrophy loss of neurons - brain shrinkage as measured by magnetic resonance imaging MRI was reduced in patients receiving simvastatin compared to those taking placebo
Several other long term studies have also reported that there might be a relationship between the rate of brain atrophy and the degree of impairment The study is designed to test the effectiveness of repurposed simvastatin 80mg in a phase 3 double blind randomised placebo controlled trial 11 in patients with secondary progressive MS SPMS to determine if the rate of disability progression can be slowed over a 3 to 45 year period
The results generated from this trial may help to improve the treatment options of people with MS In addition taking part in this trial will mean regular review by an experienced neurologist regardless of the drug that patients are randomly allocated to receive
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-003328-56 | EUDRACT_NUMBER | None | None |