MS-STAT2 - Multiple Sclerosis – Simvastatin Trial 2

Phase 1

• Conditions: Multiple sclerosis; MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-003328-56-GB
• Lead Sponsor: niversity College London Comprehensive Clinical Trials Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-31
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1180

Inclusion Criteria

1. Patients with a confirmed diagnosis of multiple sclerosis (MS) that have entered the secondary progressive stage at randomisation. 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 one point on the Expanded Disability Status Scale (EDSS), or clinical documentation of increasing disability
2. EDSS 4.0 - 6.5 (inclusive)
3. Aged 25 to 65 years old
4. Male or Female
5. Patients must be able and willing to comply with the terms of this protocol.
6. Written informed consent provided

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Relapse within 3 months of baseline visit
2. Patients that have been treated with steroids (intravenous and/or oral) due to
MS relapse/progression within 3 months of 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 creatinine kinase (CK) = 3x 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, clarithromycin, 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, grapefruit juice or alcohol abuse
7. Primary progressive MS
8. Diabetes Mellitus Type 1
9. Uncontrolled hypothyroidism
10.Female participants that are pregnant or breast feeding. Women of child bearing
potential (WOCBP) who are unwilling or unable to use an acceptable method to
avoid pregnancy for the entire study period, and up to 4 weeks after the last
dose of study drug.
11. Use of immunosuppressants (e.g. azathioprine, methotrexate, ciclosporine) or
disease modifying treatments (avonex, rebif, betaferon, glatiramer) within the
previous 6 months.
12. Use of mitoxantrone, natalizumab, alemtuzumab, daclizumab or other monoclonal antibody treatment, if treated within the last 12 months.
13. Use of fingolimod, fumarate, teriflunomide within the last 12 months.
14. Use of other experimental disease modifying treatment within the last 6 months
15. Commencement of Fampridine = 6 month from day of randomisation
16. Concurrent participation in another clinical trial of an investigational
medicinal product or medical device

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified