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

NCT02555215 | Completed Phase 3 Results DMC

• 2 other identifiers: 109MS3112015-003282-29
• Study Type: interventional
• Target: 20
• Locations: 10 countries
• Sites: 12

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

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. An SAE is 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.

  Baseline to Week 96

• Number of Participants Discontinuing Treatment Due to an Adverse Event

  An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment.

  Baseline to Week 96

Secondary Outcomes (6)

• Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 16 to Week 24

  Week 16 to Week 24

• Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 64 to Week 72

  Week 64 to Week 72

• Average Annualized Relapse Rate (ARR)

  Baseline to Week 96

• Percentage of Participants Experiencing One or More Relapses

  Baseline to Week 96

• Change From Baseline in the Degree of Disability

  Baseline to Week 96

Study Arms (1)

dimethyl fumarate

EXPERIMENTAL

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

Drug: dimethyl fumarate

Interventions

dimethyl fumarate DRUG

administered orally

Also known as: DMF, BG00012

dimethyl fumarate

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (12)

Research Site

Loma Linda, California, 92354, United States

Location

Research Site

Ghent, 9000, Belgium

Location

Research Site

Sofia, 1113, Bulgaria

Location

Research Site

Hradec Králové, 50333, Czechia

Location

Research Site

Munich, Bavaria, 80337, Germany

Location

Research Site

Göttingen, Lower Saxony, 37075, Germany

Location

Research Site

Kuwait City, 15462, Kuwait

Location

Research Site

Riga, LV-1004, Latvia

Location

Research Site

Beirut, 1107 2020, Lebanon

Location

Research Site

Gdansk, 80-952, Poland

Location

Research Site

Poznan, 60-355, Poland

Location

Research Site

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Medical Director, Overall Study Officials
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 21, 2015
• Study Start: February 22, 2016
• Primary Completion: September 24, 2018
• Study Completion: September 24, 2018
• Last Updated: November 22, 2019
• Results First Posted: November 22, 2019

Record last verified: 2019-11

Locations

US (1); LA (1); DE (2); KU (1); BE (1); PL (2); BU (1); CZ (1); TU (1); LE (1)