Clinical trial NCT02555215: Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Official title: A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Pediatrics
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).


Eligibility criteria: Key Inclusion Criteria:

* Ability of parents, legal guardians, and/or subjects to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parental or guardian consent, as appropriate, per local regulations.
* Subjects who completed, as per protocol, the previous BG00012 clinical study 109MS202 (NCT02410200) and remain on BG00012 treatment.

Key Exclusion Criteria:

* Unwillingness or inability to comply with study requirements, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
* Any significant changes in medical history occurring after enrollment in the parent Study 109MS202 (NCT02410200), including laboratory test abnormalities or current clinically significant conditions that in the opinion of the Investigator would have excluded the subject's participation from the parent study. The Investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment.
* Subjects from Study 109MS202 (NCT02410200) who could not tolerate study treatment.

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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to Week 96
measure: Number of Participants Discontinuing Treatment Due to an Adverse Event
timeFrame: Baseline to Week 96
Secondary outcomes:
measure: Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 16 to Week 24
timeFrame: Week 16 to Week 24
measure: Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 64 to Week 72
timeFrame: Week 64 to Week 72
measure: Average Annualized Relapse Rate (ARR)
timeFrame: Baseline to Week 96
measure: Percentage of Participants Experiencing One or More Relapses
timeFrame: Baseline to Week 96
measure: Change From Baseline in the Degree of Disability
timeFrame: Baseline to Week 96
measure: Number of Participants Experiencing Disability Progression
timeFrame: Baseline to Week 96
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Research Site
state: California
city: Ghent
country: Belgium
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
state: Bayern
city: Göttingen
country: Germany
facility: Research Site
state: Niedersachsen
city: Kuwait City
country: Kuwait
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Beirut
country: Lebanon
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: