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

niversity College London0 sites964 target enrollmentNovember 6, 2017

ConditionsMultiple sclerosis Nervous System Diseases Demyelinating diseases of the central nervous system

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Multiple sclerosis
Sponsor: niversity College London
Enrollment: 964
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2024 Protocol article in https://doi.org/10.1136/bmjopen-2024-086414 (added 17/09/2024)

Registry

who.int

Start Date

November 6, 2017

End Date

August 15, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity College London

Eligibility Criteria

Inclusion Criteria

•Current participant inclusion criteria as of 24/05/2020:
•1\. Patients with a confirmed diagnosis of multiple sclerosis (MS) that have entered the secondary progressive stage. Steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. Progression can be evident from either an increase of at least 1 point if EDSS score \<6, or an increase of 0\.5 points if EDSS score \=6, or clinical documentation of increasing disability
•2\. EDSS 4\.0 \- 6\.5 (inclusive)
•3\. Aged 25 to 65 years old
•4\. Patients must be able and willing to comply with the terms of this protocol
•5\. Written informed consent provided
•Previous participant inclusion criteria as of 19/10/2018:
•1\. Patients with a confirmed diagnosis of multiple sclerosis (MS) that have entered the secondary progressive stage. Steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. Progression can be evident from either an increase of at least 1 point if on the Expanded Disability Status Scale (EDSS) score \<6, or an increase of 0\.5 point if EDSS score \=6, or clinical documentation of increasing disability
•2\. EDSS 4\.0 \- 6\.5 (inclusive)
•3\. Aged 25 to 65 years

Exclusion Criteria

•Current participant exclusion criteria as of 15/11/2023:
•Current participant exclusion criteria:
•1\. Relapse within 3 months of baseline visit. Patients will be eligible where 3 months from the final day of the relapse, has elapsed by the date of the baseline visit
•2\. Patients that have been treated with steroids (intravenous and/or oral) due to MS relapse/progression within 3 months from the final day of relapse to the baseline visit. These patients may undergo a further screening visit once the 3\-month window has expired and may be included if no steroid treatment has been administered in the intervening period (Note: Patients on steroids for another medical condition may be included in the trial provided the steroid prescription is not for MS relapse/progression)
•3\. Significant organ co\-morbidity e.g. cardiac failure, renal failure, malignancy
•4\. Screening levels of alanine aminotransferase (ALT) / aspartate aminotransferase (AST) or creatine kinase (CK) \=3 x upper limit of normal (ULN)
•5\. Current use of a statin; or any use within the last 6 months
•6\. Medications that interact unfavourably with simvastatin as outlined in the current summary of product characteristics (SmPC); including but not limited to CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, fluconazole, HIV protease inhibitors (e.g. nelfinavir), boceprevir, erythromycin, clrithromycin, telithromycin, telaprevir, nefazodone, fibrates (including fenofibrates), nicotinic acid (or products containing niacin), azole anti\-fungal preparations, macrolide antibiotics, protease inhibitors, verapamil, amiodarone, amlodipine, gemfibrozil, ciclosporin, danazol, diltiazem, rifampicin, fusidic acid, elbasvir, grazoprevir, ticagrelor, daptomycin, grapefruit juice or alcohol abuse;
•7\. Primary progressive MS
•8\. Diabetes mellitus type 1