NCT00217295

Brief Summary

This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_2 multiple-sclerosis

Timeline
Completed

Started Apr 2004

Typical duration for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 22, 2005

Status Verified

June 1, 2005

First QC Date

September 14, 2005

Last Update Submit

September 14, 2005

Conditions

Multiple Sclerosis

Keywords

Relapsing-remitting multiple sclerosisBrain atrophyDisease progression

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

Secondary Outcomes (3)

  • Brain atrophy on nMRI

  • Disease progression on EDSS and MSFC

  • Relapse rate

Interventions

Avonex and TopamaxDRUG

Eligibility Criteria

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

You may qualify if:

  • Relapsing-remitting multiple sclerosis

You may not qualify if:

  • Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Sclerosis Institute

Philadelphia, Pennsylvania, 19146, United States

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDisease Progression

Interventions

Interferon beta-1aTopiramate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsFructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Jeffrey I Greenstein, MD

    MSI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey I Greenstein, MD

CONTACT

215-985-2245

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

April 1, 2004

Study Completion

December 1, 2007

Last Updated

September 22, 2005

Record last verified: 2005-06

Locations

US(1)