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

• Register: EUCTR
• Last refreshed on: 7 January 2019
• Main ID: EUCTR2015-003282-29-BG
• Date of registration: 02/03/2016
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Research Limited
• 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: 14/05/2016
• Target sample size: 18
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003282-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: Extension study for subjects completing 109MS202; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, Czech Republic, Germany, Kuwait, Latvia, Lebanon, Poland, Turkey, United States

Contacts

• Name: Clinical Trials-Neurology
• Affiliation: Biogen Idec Research Limited

• Name: Clinical Trials-Neurology
• Affiliation: Biogen Idec Research Limited

Key inclusion & exclusion criteria

Inclusion 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.

NOTE: Other protocol defined inclusion criteria may apply.

Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
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 exclusion criteria may apply.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Main Objective: The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200).

Primary end point(s): - The number of participants that experience adverse events (AEs) and serious adverse events (SAEs).
-The number of participants that discontinue study treatment due to an AE.

Secondary Objective: 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).

Timepoint(s) of evaluation of this end point: week 96

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: - total new lesions weeks at week 72
- relapse rate and proportion subjects experiencing 1 or more relapse (week 96)
-degree of disability progression up to week 24

Secondary end point(s): -The total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans.
-The annualized relapse rate
-The proportion of subjects who experience 1 or more relapses during the study period.
-The degree of disability progression from baseline as measured by the Expanded Disability Status Scale (EDSS).

Secondary ID(s)

109MS311

2015-003282-29-DE

Source(s) of Monetary Support

Biogen Idec Research Limited