Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005003-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BG00012 | Experimental | Oral BG00012 120 mg twice daily (BID) for the first 7 days followed by 240 mg BID for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans From the Baseline Period to On-Treatment Assessment Period | Baseline Period (Week -8 to Day 0), On-Treatment Assessment Period (Week 16 to Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 8 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Day 8 | |
| Apparent Clearance (CL/F) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Bernardino | California | 92408 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29681490 | Derived | Alroughani R, Das R, Penner N, Pultz J, Taylor C, Eraly S. Safety and Efficacy of Delayed-Release Dimethyl Fumarate in Pediatric Patients With Relapsing Multiple Sclerosis (FOCUS). Pediatr Neurol. 2018 Jun;83:19-24. doi: 10.1016/j.pediatrneurol.2018.03.007. Epub 2018 Mar 22. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BG00012 | BG00012 taken orally at a dose of 120 mg twice daily (BID) for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 8 |
| Apparent Volume of Distribution (V/F) | Day 8 |
| Half-Life Lambda z | Day 8 |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) | Day 8 |
| Number of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: 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. | Up to Week 28 |
| Ghent |
| B-9000 |
| Belgium |
| Research Site | Sofia | B-1113 | Bulgaria |
| Research Site | Hradec Králové | 500 05 | Czechia |
| Research Site | München | Bavaria | 80337 | Germany |
| Research Site | Göttingen | Lower Saxony | 37075 | Germany |
| Research Site | Dasman | Kuwait City | 15462 | Kuwait |
| Research Site | Riga | LV-1004 | Latvia |
| Research Site | Beirut | 1107 2020 | Lebanon |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Poznan | 60-355 | Poland |
| Research Site | Ankara | 06100 | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BG00012 | BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans From the Baseline Period to On-Treatment Assessment Period | Primary Analysis Population: participants having new or newly enlarging T2 lesions during the Baseline period with a post-baseline assessment. | Posted | Mean | Standard Deviation | lesions | Baseline Period (Week -8 to Day 0), On-Treatment Assessment Period (Week 16 to Week 24) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) | All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available. | Posted | Mean | Standard Deviation | ng/mL | Day 8 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available. | Posted | Mean | Standard Deviation | hours | Day 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Clearance (CL/F) | All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available. | Posted | Mean | Standard Deviation | L/h | Day 8 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (V/F) | All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available. | Posted | Mean | Standard Deviation | L | Day 8 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Half-Life Lambda z | All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available. | Posted | Mean | Standard Deviation | hours | Day 8 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) | All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available. | Posted | Mean | Standard Deviation | h*mcg/mL | Day 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: 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. | All participants who received at least 1 dose of BG00012. | Posted | Number | participants | Up to Week 28 |
|
|
From first dose of study drug through end of treatment period (Week 24 ±7 days) plus 4 weeks follow-up.
Treatment-emergent events are presented.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BG00012 | BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks. | 5 | 22 | 19 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA v. 19 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v. 19 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v. 19 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v. 19 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v. 19 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v. 19 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v. 19 | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | clinicaltrials@biogen.com |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Denominators |
|---|
| Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Categories |
|---|
|
| Denominators |
|---|
| Categories |
|---|
|
| Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
|