How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose (TODAY)

September 2, 2008 updated by: Biogen

An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)

This study is to find out if starting at low dose Avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of Avonex treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Coordinating Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of clinically-definite relapsing-remitting multiple sclerosis

Exclusion Criteria:

  • Any Product Information-specified contraindications to interferon-beta therapy, or other medical factors which, in the opinion of the investigator, make the subject unsuitable for interferon-beta therapy
  • Use of AVONEX, but not other interferon therapies, in the 3 months prior to randomisation into the study
  • A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomisation.
  • History of seizure in the 3 months prior to randomisation
  • History of suicidal ideation or severe depression within the 3 months prior to randomisation.
  • Other inclusion and exclusion criteria may apply per study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
titrated dose of Avonex
Drug: Interferon beta-1a
injected, once a week
Other Names:
  • Avonex
Active Comparator: 2
full dose Avonex
Drug: Interferon beta-1a
injected, once a week
Other Names:
  • Avonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the mean severity of episodes of FLS during the 4 week titration phase
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the mean severity and duration of FLS episodes in post-titration phase
Time Frame: throughout study
throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Principal Investigator: Biogen-Idec Investigator, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 14, 2007

Study Record Updates

Last Update Posted (Estimate)

September 4, 2008

Last Update Submitted That Met QC Criteria

September 2, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUS-8002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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