Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00835770
First received: February 2, 2009
Last updated: September 12, 2013
Last verified: March 2012

February 2, 2009
September 12, 2013
February 2009
June 2016   (final data collection date for primary outcome measure)
To evaluate the long-term safety profile of BG00012 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
To evaluate the long-term safety profile of BG00012 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00835770 on ClinicalTrials.gov Archive Site
To evaluate the long-term efficacy of BG00012 on clinical outcomes and MS brain lesions on MRI scans; and effects of BG00012 on quality of life measurements [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
To evaluate the long-term efficacy of BG00012 on clinical outcomes and MS brain lesions on MRI scans; and effects of BG00012 on quality of life measurements [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis
A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis

The purpose of this study is to evaluate the long-term safety and efficacy of BG00012.

Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
Drug: BG00012
240mg (two-120mg capsules) orally twice a day; 240mg (two-120mg capsules) orally three times a day. Up to 5 years in duration.
  • Experimental: 1
    BG00012 240mg BID
    Intervention: Drug: BG00012
  • Experimental: 2
    BG00012 240mg TID
    Intervention: Drug: BG00012
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1700
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

-Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 or 109MS302.

Exclusion Criteria:

  • Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study.
  • Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
  • Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.
  • Other protocol defined inclusion/exclusion criteria may apply.
Both
19 Years to 58 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Canada,   Croatia,   Czech Republic,   Estonia,   Germany,   Greece,   Guatemala,   Italy,   Latvia,   Mexico,   Netherlands,   New Zealand,   Poland,   Puerto Rico,   Romania,   Serbia,   Slovakia,   South Africa,   Spain,   Switzerland,   Ukraine,   United Kingdom
 
NCT00835770
109MS303
Not Provided
Biogen Idec MD, Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP