Role of Simvastatin in Relapsing-Remitting Multiple Sclerosis
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Simvastatin in relapsing remitting multiple sclerosis
What it measured
Main measures
EDSS
baseline, month 6, 12, 18, 24
Disability progression
Other measures (5)
Response rate on the patient reported outcome form Multiple Sclerosis Walking Scale-12 version 2
baseline, month 12 and 24
Walking and mobilityQuality of life (reported by participants)Change in time taken to complete 25-Foot Timed Walk
baseline, month 6, 12, 18 and 24
Disability progressionWalking and mobilityChange in time taken to complete 9 hole peg test
baseline, month 6, 12, 18 and 24
Disability progressionArm and hand functionmodified Rankin scale
baseline, month 12 and 24
Change in frontal lobe function based on Frontal Assessment Battery (FAB) scores
baseline, month 12 and 24
Who could take part
Relapsing MS · 18 to 65
Inclusion Criteria: * 1. Patients must have a confirmed diagnosis of multiple sclerosis according to revised Mc Donald criteria 2017 and have relapsing remitting multiple scelerosis type. 2. EDSS up to 4. 3. Males and Females aged 18 to 65 4. pregnancy test within 7 days prior to being registered/randomized. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. 5. Willing and able to comply with the trial protocol (e.g. can tolerate MRI and fullfills the requirements for MRI, e.g. not fitted with pacemakers or permanent hearing aids), with ability to understand and complete questionnaires 6. Willing and able to provide written informed consent Exclusion Criteria: * 1. Unable to give informed consent. 2. Patient with other types of multiple scelerosis (Secondary-Progressive MS (SPMS), Primary progressive MS, Progressive-Relapsing MS (PRMS) ) 3. Any medications that unfavourably interact with statins e.g.: fibrates, nicotinic acid, cyclosporin, azole anti-fungal preparations, macrolideantibiotics, protease inhibitors, nefazodone, verapamil, amiodarone, large amounts of grapefruit juice or alcohol abuse within 6 months. 4. Active Hepatic disease or known severe renal failure (creatinine clearance \<30ml/min) 5. Screening levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatine kinase (CK) are three times the upper limit of normal patients. 6. Patient unable to tolerate or unsuitable to have baseline MRI scan (e.g. metal implants, heart pacemaker) or MRI scan not of adequate quality for analysis (e.g. too much movement artefact). 7. Females who are pregnant, planning pregnancy or breastfeeding. 8. Allergy to simvastatin
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of the clinical trial is to test how Simvastatin (80mg/day) may decrease attacks and progression of disease in patients with multiple sclerosis under disease modifying therapy (DMTs)
Papers
Background
Loma I, Heyman R. Multiple sclerosis: pathogenesis and treatment. Curr Neuropharmacol. 2011 Sep;9(3):409-16. doi: 10.2174/157015911796557911.Background
Gadoth N. Multiple sclerosis in children. Brain Dev. 2003 Jun;25(4):229-32. doi: 10.1016/s0387-7604(03)00035-4.Background
Boiko A, Vorobeychik G, Paty D, Devonshire V, Sadovnick D; University of British Columbia MS Clinic Neurologists. Early onset multiple sclerosis: a longitudinal study. Neurology. 2002 Oct 8;59(7):1006-10. doi: 10.1212/wnl.59.7.1006.Background
Haas J, Korporal M, Balint B, Fritzsching B, Schwarz A, Wildemann B. Glatiramer acetate improves regulatory T-cell function by expansion of naive CD4(+)CD25(+)FOXP3(+)CD31(+) T-cells in patients with multiple sclerosis. J Neuroimmunol. 2009 Nov 30;216(1-2):113-7. doi: 10.1016/j.jneuroim.2009.06.011. Epub 2009 Jul 31.Background
Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79.
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History
Started
Jan 2020
Main results due
Jan 2022
Finished
Mar 2022
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