Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS (FOCUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02410200
Recruitment Status : Completed
First Posted : April 7, 2015
Results First Posted : April 28, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: dimethyl fumarate Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years
Actual Study Start Date : September 30, 2015
Actual Primary Completion Date : September 23, 2016
Actual Study Completion Date : September 23, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BG00012
Oral BG00012 120 mg twice daily (BID) for the first 7 days followed by 240 mg BID for 24 weeks.
Drug: dimethyl fumarate
Other Names:
  • BG00012
  • DMF




Primary Outcome Measures :
  1. Change in the Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans From the Baseline Period to On-Treatment Assessment Period [ Time Frame: Baseline Period (Week -8 to Day 0), On-Treatment Assessment Period (Week 16 to Week 24) ]

Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 8 ]
  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 8 ]
  3. Apparent Clearance (CL/F) [ Time Frame: Day 8 ]
  4. Apparent Volume of Distribution (V/F) [ Time Frame: Day 8 ]
  5. Half-Life Lambda z [ Time Frame: Day 8 ]
  6. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) [ Time Frame: Day 8 ]
  7. Number of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 28 ]
    AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Ability of parents or legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parent or legal guardian, as appropriate, as per local regulations.
  • Must have a body weight of ≥30 kg at Screening and Day 1.
  • Must have a diagnosis of RRMS according to McDonald criteria for MS (2010) [Polman 2011] and International Pediatric Multiple Sclerosis (MS) Study Group criteria for pediatric MS (2013) [Krupp 2013].

Key Exclusion Criteria:

  • Primary progressive, secondary progressive, or progressive relapsing MS (as defined by [Lublin and Reingold 1996]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.
  • Disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease, lupus erythematosus, and neuromyelitis optica), metabolic disorders (e.g., dystrophies), and infectious disorders.
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity to dimethyl fumarate or fumaric acid esters.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410200


Locations
Layout table for location information
United States, California
Research Site
San Bernardino, California, United States, 92408
Belgium
Research Site
Gent, Belgium, B-9000
Bulgaria
Research Site
Sofia, Bulgaria, B-1113
Czechia
Research Site
Hradec kralove, Czechia, 500 05
Germany
Research Site
Munchen, Bayern, Germany, 80337
Research Site
Gottingen, Niedersachsen, Germany, 37075
Kuwait
Research Site
Dasman, Kuwait City, Kuwait, 15462
Latvia
Research Site
Riga, Latvia, LV-1004
Lebanon
Research Site
Beirut, Lebanon, 1107 2020
Poland
Research Site
Gdansk, Poland, 80-952
Research Site
Poznan, Poland, 60-355
Turkey
Research Site
Ankara, Turkey, 06100
Sponsors and Collaborators
Biogen
Investigators
Layout table for investigator information
Study Director: Medical Director Biogen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02410200     History of Changes
Other Study ID Numbers: 109MS202
2014-005003-24 ( EudraCT Number )
First Posted: April 7, 2015    Key Record Dates
Results First Posted: April 28, 2017
Last Update Posted: October 23, 2017
Last Verified: September 2017
Keywords provided by Biogen:
Pediatrics
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs