Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02555215
• Date of registration: 17/09/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
• Scientific title: A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis
• Date of first enrolment: February 22, 2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02555215
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

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, 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.



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)

Number of Participants Discontinuing Treatment Due to an Adverse Event [Time Frame: Baseline to Week 96]

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline to Week 96]

Secondary Outcome(s)

Average Annualized Relapse Rate (ARR) [Time Frame: Baseline to Week 96]

Number of Participants Experiencing Disability Progression [Time Frame: Baseline to Week 96]

Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 64 to Week 72 [Time Frame: Week 64 to Week 72]

Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 16 to Week 24 [Time Frame: Week 16 to Week 24]

Change From Baseline in the Degree of Disability [Time Frame: Baseline to Week 96]

Percentage of Participants Experiencing One or More Relapses [Time Frame: Baseline to Week 96]

Secondary ID(s)

109MS311

2015-003282-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02555215