Research on the effect of add-on high dosage simvastatin treatment on progression in MS patients treated with ocrelizumab and natalizumab.

Phase 1

• Conditions: Multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-003127-38-NL
• Lead Sponsor: VUmc Neurology Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-09
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 <70 mL/min), uncontrolled hypothyroidism, personal or familial history of hereditary muscular disorders, alcohol abuse (>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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified