Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Drug: BG00012
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Up to 8 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1738
Study Start Date: February 2009
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
Drug: BG00012
BG00012 capsules
Other Names:
  • oral fumarate
  • BG-12

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 58 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835770

  Show 158 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00835770     History of Changes
Other Study ID Numbers: 109MS303
Study First Received: February 2, 2009
Last Updated: October 3, 2014
Health Authority: Israel: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Romania: National Medicines Agency
Bulgaria: Bulgarian Drug Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Switzerland: Swissmedic
Ukraine: State Pharmacological Center - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Ireland: Irish Medicines Board
Macedonia: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Guatemala: Ministry of Public Health and Social Assistance
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Ministry of Health
Bosnia: Federal Ministry of Health
Italy: Ministry of Health
Estonia: The State Agency of Medicine
Austria: Agency for Health and Food Safety
South Africa: Medicines Control Council
Czech Republic: State Institute for Drug Control
Greece: National Organization of Medicines
Slovakia: State Institute for Drug Control
Mexico: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Croatia: Ministry of Health and Social Care
Belarus: Ministry of Health
Canada: Health Canada
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
India: Drugs Controller General of India
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Moldova: Ministry of Health

Keywords provided by Biogen Idec:
relapsing
multiple sclerosis
remitting
oral

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Dimethyl fumarate
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014