NCT00492765

Brief Summary

This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a in patients with Multiple Sclerosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for phase_4 multiple-sclerosis

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_4 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 15, 2010

Status Verified

October 1, 2010

Enrollment Period

4.2 years

First QC Date

June 25, 2007

Last Update Submit

October 14, 2010

Conditions

Multiple Sclerosis

Keywords

Combination therapySimvastatinMultiple SclerosisInterferon-beta-1a

Outcome Measures

Primary Outcomes (1)

  • The time to first documented relapse

    months 4, 6, 9, 12, and every 3 months from months 18-39

Secondary Outcomes (3)

  • 3Annual rate of documented relapses after randomisation

    months 4, 6, 9, 12, and every 3 months from months 18-39

  • Number of new and/or enlarging lesions on T2-weighted MRI based on MRI done 12 months following randomisation compared with MRI done at time of randomisation

    month 15

  • Proportion of patients without disease activity after randomisation (i.e. no relapses, no increase in EDSS score and no increase in enlarging or new T2 lesions).

    months 4, 6, 9, 12, and every 6 months from months 18-39

Study Arms (2)

1

EXPERIMENTAL

interferon beta-1a and Simvastatin

Drug: Interferon-beta-1aDrug: Simvastatin

2

PLACEBO COMPARATOR

Interferon beta-1a and Placebo

Drug: Interferon-beta-1aDrug: Placebo

Interventions

Interferon-beta-1aDRUG

dosage and frequency as per label

Also known as: Avonex
12
SimvastatinDRUG

dosage and frequency as per Biogen Idec protocol

1
PlaceboDRUG

dosage and frequency the same as simvastatin as per Biogen Idec Protocol

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Is between the age of 18 and 55 years (both included)
  • Relapsing-remitting MS according to Poser criteria (CDMS or LSDMS) 22 or definite MS according to McDonald criteria 23
  • Disability equivalent to an EDSS of 5.5 or less 21
  • Clinical activity defined as at least one reported or documented relapse within the last year
  • Patient must be prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn

You may not qualify if:

  • Any condition that might give rise to similar symptoms as MS
  • History of major depression
  • Alcohol or drug dependency
  • Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
  • Significant hypertension (BP \> 180/110 mmHg)
  • Renal insufficiency defined as serum creatinine \> 1.5 times the upper normal reference limit
  • Total plasma cholesterol \< 3.5 mmol/L
  • Any medical illness requiring treatment with systemic corticosteroids
  • Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
  • Women who are pregnant, breast-feeding or have the possibility for pregnancy during the study. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coordinating Research Site

Copenhagen, Denmark

Location

Related Publications (1)

  • Sorensen PS, Lycke J, Eralinna JP, Edland A, Wu X, Frederiksen JL, Oturai A, Malmestrom C, Stenager E, Sellebjerg F, Sondergaard HB; SIMCOMBIN study investigators. Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial. Lancet Neurol. 2011 Aug;10(8):691-701. doi: 10.1016/S1474-4422(11)70144-2.

    PMID: 21742556DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1aSimvastatin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 27, 2007

Study Start

February 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 15, 2010

Record last verified: 2010-10

Locations

DK(1)