Trial record 2 of 2 for:
109MS202
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS (FOCUS)
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| ClinicalTrials.gov Identifier: NCT02410200 |
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Recruitment Status :
Completed
First Posted : April 7, 2015
Results First Posted : April 28, 2017
Last Update Posted : October 23, 2017
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Sponsor:
Biogen
Information provided by (Responsible Party):
Biogen
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 22 participants |
| Allocation: | N/A |
| 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
MedlinePlus Genetics related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: BG00012
Oral BG00012 120 mg twice daily (BID) for the first 7 days followed by 240 mg BID for 24 weeks.
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Drug: dimethyl fumarate
Other Names:
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Primary Outcome Measures :
- 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 :
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 8 ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 8 ]
- Apparent Clearance (CL/F) [ Time Frame: Day 8 ]
- Apparent Volume of Distribution (V/F) [ Time Frame: Day 8 ]
- Half-Life Lambda z [ Time Frame: Day 8 ]
- Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) [ Time Frame: Day 8 ]
- 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.
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| 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
| 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
| Study Director: | Medical Director | Biogen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT02410200 |
| 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:
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Pediatrics |
Additional relevant MeSH terms:
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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 |