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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02410200
Other study ID # 109MS202
Secondary ID 2014-005003-24
Status Completed
Phase Phase 2
First received April 2, 2015
Last updated September 21, 2017
Start date September 30, 2015
Est. completion date September 23, 2016

Study information

Verified date September 2017
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date September 23, 2016
Est. primary completion date September 23, 2016
Accepts healthy volunteers No
Gender All
Age group 10 Years to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
dimethyl fumarate


Locations

Country Name City State
Belgium Research Site Gent
Bulgaria Research Site Sofia
Czechia Research Site Hradec kralove
Germany Research Site Gottingen Niedersachsen
Germany Research Site Munchen Bayern
Kuwait Research Site Dasman Kuwait City
Latvia Research Site Riga
Lebanon Research Site Beirut
Poland Research Site Gdansk
Poland Research Site Poznan
Turkey Research Site Ankara
United States Research Site San Bernardino California

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Czechia,  Germany,  Kuwait,  Latvia,  Lebanon,  Poland,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline Period (Week -8 to Day 0), On-Treatment Assessment Period (Week 16 to Week 24)
Secondary Maximum Observed Plasma Concentration (Cmax) Day 8
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) Day 8
Secondary Apparent Clearance (CL/F) Day 8
Secondary Apparent Volume of Distribution (V/F) Day 8
Secondary Half-Life Lambda z Day 8
Secondary Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) Day 8
Secondary Number of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) 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. Up to Week 28
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