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

This study is enrolling participants by invitation only.

First Received: February 2, 2009 Last Updated: February 3, 2009 History of Changes

Sponsored by:	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

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety Study
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

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 ]

Estimated Enrollment:	1700
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.

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

No Contacts or Locations Provided

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Biogen Idec ( Biogen Idec MD )
Study ID Numbers:	109MS303
Study First Received:	February 2, 2009
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00835770 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

multiple sclerosis
relapsing
remitting
oral

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Radiation-Sensitizing Agents
Immunologic Factors
Demyelinating Diseases
Dimethyl fumarate

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

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Nervous System Diseases
Dimethyl fumarate
Sclerosis
Multiple Sclerosis, Relapsing-Remitting

Immunosuppressive Agents
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Demyelinating Autoimmune Diseases, CNS
Dermatologic Agents
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009