Efficacy of add-on high-dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial.

Efficacy of add-on high-dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial. - SIMSON trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49976

Enrollment

100

Registered

2020-03-24

Start date

2020-01-06

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS Multiple sclerosis

Interventions

Add-on high-dose simvastatin 80 mg per day for 17 months (40 mg per day in month 7).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Definite diagnosis of multiple sclerosis (MS) according to the revised McDonald 2017 criteria. 2. Treatment with ocrelizumab or natalizumab for at least 6 months prior to inclusion. 4. Age 18 to 65 years old. 5. EDSS score 3.0 - 7.0 (inclusive).

Exclusion criteria

Exclusion criteria: 1. MS relapse within 6 months of baseline visit, with or without treatment with steroids. 2. Use of immunomodulation or -suppression other than ocrelizumab or natalizumab within the previous 6 months. 3. Commencement of treatment with fampridine within 3 months of baseline visit. 4. Concomitant use of lipid lowering drugs or use within 6 months before baseline visit. 5. Concomitant use of potent CYP3A4 inhibitors. 6. (History of) hypersensitivity, muscular toxicity or other adverse reaction due to statin or fibrate use. 7. Any predisposing factor to rhabdomyolysis: renal impairment (creatinine clearance 14 standard drinks units per week). 8. Baseline serum creatine kinase (CK) levels of >5 x ULN (confirmed by second measurement within 5-7 days), or at least 3-fold increase from baseline with associated muscle symptoms. 9. Active liver disease or unexplained persistent elevations of serum transaminases 3 x ULN.

Design outcomes

Primary

Measure	Time frame
The change in whole brain atrophy rate, comparing rates during 6-month run-in period to 18-month treatment period.	—

Secondary

Measure	Time frame
Secondary outcome measures include clinical outcome measures (neurological exam, arm- and walking functions, cognitive functions), biochemical outcome measures (sNfL, multi-parameter analysis of peripheral blood mononuclear cells (PBMC) and serum cholesterol), other imaging outcome measures (regional white and gray matter atrophy rate, functional connectivity on brain MRI, OCT), patient-reported outcome measures (questionnaires on the impact of MS on arm function, walking function, neuropsychological status and quality of life) and safety and tolerability (incidence of (serious) adverse events, CK levels).	—

Measure

Time frame

Secondary outcome measures include clinical outcome measures (neurological exam, arm- and walking functions, cognitive functions), biochemical outcome measures (sNfL, multi-parameter analysis of peripheral blood mononuclear cells (PBMC) and serum cholesterol), other imaging outcome measures (regional white and gray matter atrophy rate, functional connectivity on brain MRI, OCT), patient-reported outcome measures (questionnaires on the impact of MS on arm function, walking function, neuropsychological status and quality of life) and safety and tolerability (incidence of (serious) adverse events, CK levels).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)