Phase 2
N=140
Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00647348 ↗Enrolled (actual)
140
Serious AEs
16.4%
Results posted
Dec 2019
Primary outcome: Primary: Percentage Change in Whole Brain Volume — 0.288; 0.584 percentage of brain volumen change — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Simvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Whole Brain Volume |
0.288; 0.584 | 0.003 sig |
| SECONDARY Evaluation of Disability (EDSS). |
5.93; 6.35 | 0.05 |
| SECONDARY Evaluation of Disability (MSFC Z Score). |
-0.78; -1.21 | — |
| SECONDARY Evaluation of Disability (MSFC Walk). |
1.83; 1.55 | — |
| SECONDARY Evaluation of Disability (MSFC Peg Test). |
0.033; 0.033 | — |
| SECONDARY Evaluation of Disability (MSFC PASAT). |
38.3; 35.2 | — |
| SECONDARY Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Total Score) |
70.1; 76.1 | — |
| SECONDARY Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Physical Score) |
51.7; 56.3 | — |
| SECONDARY Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Psychological Score) |
18.3; 19.8 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00647348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.