NCT00616187

Brief Summary

A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

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

October 1, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
Last Updated

March 20, 2018

Status Verified

December 1, 2017

Enrollment Period

3.7 years

First QC Date

February 5, 2008

Last Update Submit

March 19, 2018

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • number of MRI contrast enhancing lesions

    treatment months 6 to 9 compared to baseline

Secondary Outcomes (1)

  • other MRI-based parameters (CEL volume, T2-lesion load, T1-hypointense lesion volume, whole brain magnetization transfer ratio, and apparent diffusion coefficient of normal appearing white matter)

    treatment months 6 to 9 compared to baseline

Study Arms (2)

interferon

ACTIVE COMPARATOR
Drug: interferon beta treatment to add-on atorvastatin treatment

untreated

SHAM COMPARATOR
Drug: untreated to atorvastatin treatment

Interventions

interferon beta treatment to add-on atorvastatin treatmentDRUG

IFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)

interferon
untreated to atorvastatin treatmentDRUG

no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)

untreated

Eligibility Criteria

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

You may qualify if:

  • years old
  • MS diagnosis according McDonald criteria
  • Relapsing-remitting MS
  • EDSS 0 - 6
  • Disease activity as occurrence of CEL in brain MRI
  • IFN-beta therapy for at least 6 months

You may not qualify if:

  • Primary chronic progressive MS
  • Symptoms and signs of clinical disease conditions similar to MS
  • Conditions that can disturb MRI measurements
  • Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus pepticum
  • Clinically relevant lung, heart, CNS, infectious disease
  • Clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific clinical chemistry values)
  • Allergies towards Gd-DTPA
  • Allergies towards constituents of the therapeutic agent
  • Recruitment to other clinical trials within 6 months prior to or during this study
  • Pretreatment with complete lymph irradiation, antibody therapy against lymphocyte populations (eg. anti-CD4, Campath-1H), mitoxantrone, cyclophosphamide, cyclosporin A, human antibodies, all immunomodulatory or immunosuppressive agents including recombinant cytokines or other potential experimental MS therapies (6 months prior to study start), glatiramer acetate, azathioprine, IVIg (6 months prior to study start) pregnancy or lactation
  • Alcohol or drug abuse
  • Inhibitors of Cytochrom P 450 3A (eg. cyclosporin, macrolide antibiotics, azole antimycotics).
  • Medical or psychological conditions that could hamper with the patients capacity to understand patient information, to give the informed consent, to adhere to the protocol of the study and to be able to complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Paul F, Waiczies S, Wuerfel J, Bellmann-Strobl J, Dorr J, Waiczies H, Haertle M, Wernecke KD, Volk HD, Aktas O, Zipp F. Oral high-dose atorvastatin treatment in relapsing-remitting multiple sclerosis. PLoS One. 2008 Apr 9;3(4):e1928. doi: 10.1371/journal.pone.0001928.

    PMID: 18398457DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

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

Study Officials

  • Frauke Zipp, MD

    Cecilie Vogt Clinic for Neurology, Charite, Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 15, 2008

Study Start

October 1, 2003

Primary Completion

June 1, 2007

Last Updated

March 20, 2018

Record last verified: 2017-12