NCT00146068

Brief Summary

The purpose of this study is to determine the safety, tolerability and efficacy of a combination therapy interferon beta-1a(Avonex) plus simvastatin (Zocor) vs. interferon beta-1a plus placebo in patients with clinically isolated syndrome suggestive of Multiple Sclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 multiple-sclerosis

Timeline
Completed

Started Sep 2004

Typical duration 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

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 5, 2008

Status Verified

February 1, 2008

Enrollment Period

3.2 years

First QC Date

September 1, 2005

Last Update Submit

February 28, 2008

Conditions

Multiple Sclerosis

Keywords

Clinically Isolated Syndrome

Outcome Measures

Primary Outcomes (3)

  • The primary objective of this study is to determine whether combination therapy with IFNb-1a plus simvastatin, when compared to IFNb-1a plus placebo decreases or delays additional clinical or MRI activity.

  • We will use the following outcome measures:

  • Relapse rates, Time to first relapse,Number of new T2 lesions, Number of new Gd-enhancing lesions

Interventions

Avonex/ZocorDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject has a diagnosis of CIS suggestive of MS involving optic nerve (unilateral optic neuritis), spinal cord (incomplete transverse myelitis), brain stem or cerebellum syndrome confirmed by ophthalmologic or neurological examinations. (Onset of CIS symptoms must occur within twelve months of randomization).
  • At baseline, subject will be between the ages of 18 and 60, inclusive.
  • Subject has a baseline EDSS score between 0.0 and 5.5, inclusive.
  • MRI findings on the brain scan should reveal at least three out the four following findings: one Gd-enhancing lesion or nine T2 hyperintense lesions; or at least one infratentorial lesion; or at least one juxtacortical lesion and or at least three periventricular lesions.
  • Subject has signed informed consent and HIPAA forms.

You may not qualify if:

  • Subject has a diagnosis of CD RRMS according to Poser criteria, definitive MS according McDonald criteria, secondary progressive, or primary progressive MS.
  • Subject has been treated with statins in the previous three months. Subject has history of severe side effects related to statin therapy.
  • Subject has had a clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomization.
  • Subject has a history of, or abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, and/or other major disease.
  • Subject has a history of severe allergic or anaphylactic reactions or known drug hypersensitivity.
  • Subject has an abnormal screening blood test, performed at the screening visit, exceeding any of the limits defined below:
  • alanine transaminase (ALT) or aspartate transaminase (AST) \> 1.5 times the upper limit of normal (1.5x ULN)
  • total white blood cell count \< 2,300/mm\^3
  • CPK level \> 2 x ULN on two consecutive occasions tested at least one week apart.
  • Platelets less than 150,00/mm3
  • Creatinine \> 1.5mg/dl.
  • prothrombin time (PT) \> ULN
  • Subject has history of treatment with either interferon-beta 1a or 1b, or glatiramer acetate.
  • Subject has had any prior treatment with any of the following medications:
  • total lymphoid irradiation
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina-Chapel Hill MS clinic within the Neuroscience Hospital

Chapel Hill, North Carolina, 27599, United States

Location

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 Officials

  • Silva Markovic-Plese

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

September 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 5, 2008

Record last verified: 2008-02

Locations

US(1)