Status unknownPhase 1Relapsing MSNCT04178980

We could not find results for this trial

I know where the results are

What it found

No result 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 mobility
  • Change in time taken to complete 9 hole peg test

    baseline, month 6, 12, 18 and 24

    Disability progressionArm and hand function
  • modified 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

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Related trials

History

    1. Started

      Jan 2020

    2. Main results due

      Jan 2022

    3. Finished

      Mar 2022

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