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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— FOCUS  

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

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
• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

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