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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02410200
• Date of registration: 02/04/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS FOCUS
• Scientific 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
• Date of first enrolment: September 30, 2015
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02410200
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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.



Age minimum: 10 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: dimethyl fumarate

Primary Outcome(s)

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(s)

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]

Apparent Volume of Distribution (V/F) [Time Frame: Day 8]

Half-Life Lambda z [Time Frame: Day 8]

Apparent Clearance (CL/F) [Time Frame: Day 8]

Time to Reach Maximum Observed Plasma Concentration (Tmax) [Time Frame: Day 8]

Maximum Observed Plasma Concentration (Cmax) [Time Frame: Day 8]

Secondary ID(s)

2014-005003-24

109MS202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02410200