Trial record 1 of 307 for:    "Multiple Sclerosis, Relapsing-Remitting"
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BG00012 Phase 2 Combination Study in Subjects With Multiple Sclerosis (EXPLORE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01156311
First received: July 1, 2010
Last updated: September 12, 2013
Last verified: May 2012
  Purpose

This is an open-label, multicenter, study. Subjects receiving an IFNβ (Avonex, Rebif, or Betaseron) or GA as monotherapy will be enrolled. Safety, efficacy, and pharmacodynamics (PD) will be assessed during the monotherapy period and the subsequent 6 month combination treatment period with BG00012.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Relapsing-remitting
Multiple Sclerosis
Drug: BG00012
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNβ) or Glatiramer Acetate (GA)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • The primary objective of the study is to evaluate the safety and tolerability of BG00012 administered in combination with IFNβ or GA in subjects with RRMS. [ Time Frame: 9 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Explore the efficacy of BG00012 in combination with IFNβ or GA. [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
  • Explore the effect of combination therapy on potential biomarkers of BG00012 and neopterin for IFNβ and IFNβ with BG00012. [ Time Frame: 9 Months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BG00012
BG00012 240 mg (2 capsules) TID.
Drug: BG00012
Dimethyl Fumarate

Detailed Description:

BG00012 is being investigated to determine whether it is viable agent to consider for use in combination with other MS therapies.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 to 55 years old, inclusive, at the time of informed consent.
  • Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4 (Polman et al, 2005 [Appendix I]), and have a prior brain MRI demonstrating lesion (s) consistent with MS from any point in time.
  • Must have an EDSS between 0.0 and 5.0, inclusive.
  • Must be taking the same dose of a prescribed IFNβ (either Avonex, Betaseron, Rebif) or GA for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. Subjects receiving Rebif must be prescribed 44 μg by subcutaneous injection three times per week.

Exclusion Criteria:

  • Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Polman et al. 2005
  • Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
  • Pregnant or nursing women.
  • Participation within 6 months prior to study enrollment in any other drug, biologic, or device study.

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: NCT01156311

  Show 21 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01156311     History of Changes
Other Study ID Numbers: 109MS201
Study First Received: July 1, 2010
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
oral
BG00012
MS
RRMS

Additional relevant MeSH terms:
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Sclerosis
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 July 24, 2014