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NCT00179478 · ClinicalTrials.gov registry record · Phase 4

Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis

A Phase 4 study of Multiple Sclerosis and Optic Neuritis, sponsored by Beth Israel Deaconess Medical Center.

Completed
Registry status
Phase 4
Development phase
155
Enrollment target
20
Study locations

NCT00179478 is a Phase 4 study of Multiple Sclerosis and Optic Neuritis that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 155 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT00179478, a Phase 4 study of Multiple Sclerosis and Optic Neuritis, has completed, sponsored by Beth Israel Deaconess Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
155 participants
Enrollment target
20
Study locations

Study Summary

The current study is a continuation of the 5 year extension study of the phase III CHAMPS study (see reference). This study was designed to determine if immediate initiation of therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS) continues to delay the development of further attacks (CDMS) and the development of neurological disability over a 10 year period of observation. The initial 5 year extension study, called CHAMPIONS5, reported that immediate initiation of interferon Beta-1a (AVONEX) after a first attack of MS continued to delay the development of CDMS and lowered relapse rates compared to delayed initiation of disease modifying treatment (usually with AVONEX) either at the time of a second attack or at the end of the phase III study (24 months). The study was extended to 10 years to determine if these effects are sustained and result in less long term permanent disability.

Conditions Studied

Multiple Sclerosis Optic Neuritis Transverse Myelitis Acute Brainstem/Cerebellar Syndrome

Interventions

  • DRUG interferon beta 1a 30 ug IM once weekly

Study Locations (20)

Pennsylvania

  • The Neurology Group - Norristown
  • Univeristy of Pennsylvania Medical Center - Philadelphia
  • Allegheny Neurological Associates - Pittsburgh

New York

  • Jacobs Neurological Institute - Buffalo
  • University of Rochester - Rochester

Ohio

  • Cleveland Clinic Foundation - Cleveland
  • The Ohio State University - Columbus

Virginia

  • Virginia Commonwealth University/Medical College of Virginia - Richmond
  • Neurological Associates, Inc. - Richmond

Connecticut

  • MS Treatment Center at Griffin Hospital - Derby

Florida

  • Jaeb Center for Health Research - Tampa

Georgia

  • MS Center of Atlanta - Atlanta

Illinois

  • Beta Research, Inc - Elk Grove

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2001-02
Est. Completion 2009-03
Phase Phase 4

Sponsor

Beth Israel Deaconess Medical Center

488 total trials

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What the Registry Record Tells You About NCT00179478

The ClinicalTrials.gov registry entry for NCT00179478 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (74% lower). The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which interferon beta 1a 30 ug IM once weekly is the first listed.

NCT00179478 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Pennsylvania, New York, Ohio.

Frequently Asked Questions

What is clinical trial NCT00179478 about?

NCT00179478 is a clinical study titled "Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis". The current study is a continuation of the 5 year extension study of the phase III CHAMPS study (see reference). This study was designed to determine if immediate initiation of therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS) continues to delay the development...

What is the current status of trial NCT00179478?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 155 participants. The study started on 2001-02. Estimated completion is 2009-03.

What conditions does trial NCT00179478 study?

This clinical trial studies the following conditions: Multiple Sclerosis, Optic Neuritis, Transverse Myelitis, Acute Brainstem/Cerebellar Syndrome.

What interventions are being tested in trial NCT00179478?

The interventions under investigation include: interferon beta 1a 30 ug IM once weekly (DRUG).

Who is sponsoring clinical trial NCT00179478?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00179478 being conducted?

This trial has 20 study locations across Connecticut, Florida, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.