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Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis

NCT ID: NCT00647348

Last Updated: 2019-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-11-30

Brief Summary

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To determine whether simvastatin at a dose of 80mg can reduce the rate of whole brain atrophy, as measured by MRI, over a 2-year time-period when compared to placebo.

Detailed Description

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The study has now completed see Primary publication:

Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial.

Chataway J, Schuerer N, Alsanousi A, Chan D, MacManus D, Hunter K, Anderson V, Bangham CR, Clegg S, Nielsen C, Fox NC, Wilkie D, Nicholas JM, Calder VL, Greenwood J, Frost C, Nicholas R.

Lancet. 2014 Jun 28;383(9936):2213-21. doi: 10.1016/S0140-6736(13)62242-4.

Conditions

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Secondary Progressive Multiple Sclerosis

Keywords

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Secondary progressive Multiple Sclerosis Simvastatin MRI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
over-encapsulation of IMP

Study Groups

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1

Simvastatin 80mg OD

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

80mg simvastatin oral once daily for 24 months

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral placebo tablet once daily for 24 months

Interventions

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Simvastatin

80mg simvastatin oral once daily for 24 months

Intervention Type DRUG

Placebo

Oral placebo tablet once daily for 24 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have a confirmed diagnosis of multiple sclerosis and at randomisation 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 one point on the EDSS or clinical documentation of increasing disability.
* EDSS 4.0 - 6.5 inclusive
* Women of childbearing age will be required to use appropriate methods of contraception to avoid the unlikely teratogenic effects of simvastatin.
* Able to give written informed consent
* 18 - 65 years

Exclusion Criteria

* Unable to give informed consent
* Primary progressive MS
* Those that have experienced a relapse or have been treated with steroids (both i.v. and oral) within 3 months of the screening 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.
* Patient is already taking or is anticipated to be taking a statin.
* Any medications that unfavourably interact with statins: fibrates, nicotinic acid, cyclosporine, azole anti-fungal preparations, macrolideantibiotics, protease inhibitors, nefazodone, verapamil, amiodarone, large amounts of grapefruit juice or alcohol abuse.
* The use of immunosuppressants (e.g. azathioprine, methotrexate, cyclosporine) or disease modifying treatments (avonex, rebif, betaferon, glatiramer) within the previous 6 months.
* The use of mitoxantrone if treated within the last 12 months.
* If the patient has ever been treated with alemtuzumab.
* If screening levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatine kinase (CK) are three times the upper limit of normal patients should be excluded.
* Patient unable to tolerate baseline scan or scan not of adequate quality for analysis (e.g. too much movement artefact).
* If a female patient is pregnant or breast feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy Chataway, MB BCh, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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MRI Unit, National Society for Epilepsy, Chesham Lane

Chalfont Saint Peter, Buckinghamshire, United Kingdom

Site Status

Charing Cross Hospital, Fulham Palace Road

Hammersmith, London, United Kingdom

Site Status

Brighton & Sussex University Hospitals NHS Trust, Eastern Road

Brighton, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Chan D, Binks S, Nicholas JM, Frost C, Cardoso MJ, Ourselin S, Wilkie D, Nicholas R, Chataway J. Effect of high-dose simvastatin on cognitive, neuropsychiatric, and health-related quality-of-life measures in secondary progressive multiple sclerosis: secondary analyses from the MS-STAT randomised, placebo-controlled trial. Lancet Neurol. 2017 Aug;16(8):591-600. doi: 10.1016/S1474-4422(17)30113-8. Epub 2017 Jun 7.

Reference Type RESULT
PMID: 28600189 (View on PubMed)

Chataway J, Schuerer N, Alsanousi A, Chan D, MacManus D, Hunter K, Anderson V, Bangham CR, Clegg S, Nielsen C, Fox NC, Wilkie D, Nicholas JM, Calder VL, Greenwood J, Frost C, Nicholas R. Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial. Lancet. 2014 Jun 28;383(9936):2213-21. doi: 10.1016/S0140-6736(13)62242-4. Epub 2014 Mar 19.

Reference Type RESULT
PMID: 24655729 (View on PubMed)

Williams TE, Holdsworth KP, Nicholas JM, Eshaghi A, Katsanouli T, Wellington H, Heslegrave A, Zetterberg H, Frost C, Chataway J. Assessing Neurofilaments as Biomarkers of Neuroprotection in Progressive Multiple Sclerosis: From the MS-STAT Randomized Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Jan 14;9(2):e1130. doi: 10.1212/NXI.0000000000001130. Print 2022 Mar.

Reference Type DERIVED
PMID: 35031587 (View on PubMed)

Other Identifiers

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MREC: 07/Q1602/73

Identifier Type: OTHER

Identifier Source: secondary_id

2006-006347-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MSTC-001

Identifier Type: -

Identifier Source: org_study_id