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

NCT ID: NCT02555215

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-22
• Study Completion Date: 2018-09-24

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).

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dimethyl fumarate

Participants will receive 120 mg capsule(s) taken orally.

Group Type: EXPERIMENTAL

dimethyl fumarate

Intervention Type: DRUG

administered orally

Interventions

dimethyl fumarate

administered orally

Intervention Type: DRUG

Other Intervention Names

DMF; BG00012

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Loma Linda, California, United States

Research Site

Ghent, , Belgium

Research Site

Sofia, , Bulgaria

Research Site

Hradec Králové, , Czechia

Research Site

Munich, Bavaria, Germany

Research Site

Göttingen, Lower Saxony, Germany

Research Site

Kuwait City, , Kuwait

Research Site

Riga, , Latvia

Research Site

Beirut, , Lebanon

Research Site

Gdansk, , Poland

Research Site

Poznan, , Poland

Research Site

Ankara, , Turkey (Türkiye)

Countries

United States; Belgium; Bulgaria; Czechia; Germany; Kuwait; Latvia; Lebanon; Poland; Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-003282-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109MS311

Identifier Type: -

Identifier Source: org_study_id