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

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00835770

Purpose

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

Condition	Intervention	Phase
Relapsing-Remitting Multiple Sclerosis	Drug: BG00012	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (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:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To evaluate the long-term safety profile of BG00012 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	1700
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 BG00012 240mg BID	Drug: BG00012 240 mg (two-120 mg capsules) orally twice a day; 240 mg (two-120 mg capsules) orally three times a day. Up to 2 years in duration.
Experimental: 2 BG00012 240mg TID	Drug: BG00012 240 mg (two-120 mg capsules) orally twice a day; 240 mg (two-120 mg capsules) orally three times a day. Up to 2 years in duration.

Detailed Description:

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.

Eligibility

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

Criteria

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.

Contacts and Locations

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

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Sponsors and Collaborators

Biogen Idec

More Information

No publications provided

Responsible Party:	Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier:	NCT00835770 History of Changes
Other Study ID Numbers:	109MS303
Study First Received:	February 2, 2009
Last Updated:	September 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

relapsing
multiple sclerosis
remitting
oral

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

Pathologic Processes
Dimethyl fumarate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 09, 2012