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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00835770
First received: February 2, 2009
Last updated: October 3, 2014
Last verified: October 2014

February 2, 2009
October 3, 2014
February 2009
August 2019   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events [ Time Frame: Up to 8 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
  • Number of Participants Who Had Relapses [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
  • Annualized Relapse Rate (ARR) [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
  • Change from Baseline in the Expanded Disability Status Scale (EDSS) up to 8 years [ Time Frame: Day 1 (baseline), up to 8 years ] [ Designated as safety issue: No ]
    Progression of disability is defined as at least a 1.0 point increase on the EDSS from baseline EDSS 1.0 that is sustained for 24 weeks or at least a 1.5 point increase on the EDSS from baseline EDSS =0 that is sustained for 24 weeks.
  • Number and volume of Gd-enhancing lesions as Measured by Magnetic Resonance Imaging (MRI) [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
  • Number and volume of new or newly-enlarging T2 lesions as Measured by Magnetic Resonance Imaging (MRI) [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
  • Number and volume of T1 hypointense lesions [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
  • Change from Baseline in Brain atrophy up to 8 years [ Time Frame: Day 1 (baseline), up to 8 years ] [ Designated as safety issue: No ]
  • Summary of Magnetization Transfer Ratio (MTR) [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
    MTR is used in neuroradiology to highlight abnormalities in brain structures
  • Change from Baseline in EQ-5D Health Survey (EQ-5D) up to 8 years [ Time Frame: Day 1 (baseline), up to 8 years ] [ Designated as safety issue: No ]
    EQ-5D measures quality of life.
  • Change from baseline in SF-36® Health Survey (SF-36) up to 8 years [ Time Frame: Day 1 (baseline), up to 8 years ] [ Designated as safety issue: No ]
  • Change from Baseline in Visual Function test scores up to 8 years [ Time Frame: Day 1 (baseline), up to 8 years ] [ Designated as safety issue: No ]
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 Extension 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 primary objective of this study is to evaluate the long-term safety and efficacy of BG00012. Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301(NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.

The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the initiation of this study, BG00012 was approved in several countries for the treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this study at the time Protocol Version 3 is implemented will receive the currently marketed dose of 240 mg BID. Upon approval of Protocol Version 3, participants currently receiving BG00012 240 mg TID will be switched to BID dosing at their next scheduled visit.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
  • Drug: BG00012
    BG00012 capsules
    Other Names:
    • oral fumarate
    • BG-12
  • Drug: Placebo
    Capsules taken to maintain the blind in the 240 mg BID treatment group.
  • Experimental: BG00012 240 mg BID
    In the first phase, participants will receive BG00012 240 mg twice a day (BID; two 120 mg capsules twice a day) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for up to 8 years.
    Interventions:
    • Drug: BG00012
    • Drug: Placebo
  • Experimental: BG00012 240 mg TID
    In the first phase participants will receive BG00012 240 mg three times a day (TID) . In the second phase participants will receive open-label BG00012 240 mg BID for up to 8 years.
    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
1738
August 2019
August 2019   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

-Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).

Key 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.

NOTE: 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
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
October 2014

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