Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

Relapsing-Remitting Multiple Sclerosis Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02428218
• Other study ID #: 109MS309
• Secondary ID: 2014-005624-98
• Status: Withdrawn
• Phase: Phase 3
• First received: April 23, 2015
• Last updated: April 11, 2016
• Start date: May 2016
• Est. completion date: January 2027

Study information

• Verified date: April 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyRomania: National Agency for Medicines and Medical DevicesSpain: Spanish Agency for Medicines and Health ProductsSlovenia: Agency for Medicinal Products - Ministry of HealthUnited States: Food and Drug AdministrationBosnia: Federal Ministry of HealthKuwait: Ministry of HealthSerbia: Medicines and Medical Devices Agency of SerbiaItaly: The Italian Medicines AgencyEstonia: The State Agency of MedicineAustria: Agency for Health and Food SafetyRussia: Ministry of Health of the Russian FederationPeru: Instituto Nacional de SaludCroatia: Agency for Medicinal Product and Medical DevicesHungary: National Institute of PharmacyCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the efficacy of oral BG00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to evaluate the safety and tolerability of BG00012 and to compare the effect of BG00012 with placebo on additional clinical and radiological measures of disease activity.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Key Inclusion Criteria:

• Informed consent and assent as appropriate

• Must have a body weight of =30 kg

• Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric multiple sclerosis (MS)

• Must be ambulatory with a converted Krutzke Baseline Expanded Disability Status Scale (EDSS) score between 0 and 5.0, inclusive

Key Exclusion Criteria:

• Primary progressive, secondary progressive, or progressive relapsing MS.

• History of disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.

• History of severe allergic or anaphylactic reactions, or known drug hypersensitivity to dimethyl fumarate (DMF) or fumaric acid esters.

• Prior treatment with any of the following medications within 12 months prior to randomization: mitoxantrone, cyclophosphamide, rituximab.

• Prior treatment with any of the following medications or procedures within 6 months prior to randomization: fingolimod, teriflunomide, natalizumab, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (IV) immunoglobulin, plasmapheresis or cytapheresis.

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Forms of Multiple Sclerosis
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
enteric-coated microtablets
• Placebo
enteric-coated microtablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first multiple sclerosis (MS) relapse	Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.	Up to week 104	No
Secondary	Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)		Up to week 104	No
Secondary	Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans		Weeks 24, 48, 72 and 96	No
Secondary	Number of gadolinium-enhancing Lesions		Baseline, and weeks 24, 48, 72 and 96	No
Secondary	Annualized MS relapse rate		weeks 48 and 96	No