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

Relapsing Remitting Multiple Sclerosis Clinical Trial

— TODAY  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00574041
• Other study ID #: AUS-8002
• Status: Terminated
• Phase: Phase 4
• First received: December 12, 2007
• Last updated: September 2, 2008
• Start date: June 2007
• Est. completion date: February 2008

Study information

• Verified date: September 2008
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis

Intervention

Drug:
• Interferon beta-1a
injected, once a week

Locations

Country	Name	City	State
Australia	Coordinating Research Site	Malvern	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the mean severity of episodes of FLS during the 4 week titration phase		4 weeks	Yes
Secondary	To assess the mean severity and duration of FLS episodes in post-titration phase		throughout study	Yes