A Phase 3 interventional study of dimethyl fumarate in Multiple Sclerosis, Relapsing-Remitting, sponsored by Biogen. Completed at 12 sites in 10 countries. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-11-22.
Sponsored by Biogen · Phase 3, Interventional, and Treatment
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).
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Participants will receive 120 mg capsule(s) taken orally.
Drug: dimethyl fumarate
administered orally
Also known as: DMF, BG00012
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.
Time frame: 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.
Time frame: Baseline to Week 96
Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 16 to Week 24
T2 hyperintense lesions were measured by MRI brain scans.
Time frame: Week 16 to Week 24
Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 64 to Week 72
T2 hyperintense lesions were measured by MRI brain scans.
Time frame: Week 64 to Week 72
Average Annualized Relapse Rate (ARR)
Relapses were 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 Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids. The ARR was calculated as the total number of relapses that occurred during the previous 12 months and during the 120 weeks on treatment for participants in Study 109MS202 that continued into Study 109MS311, divided by the total number of person-years followed prior to the study and by the total number of person-years followed during the study, respectively.
Time frame: Baseline to Week 96
Percentage of Participants Experiencing One or More Relapses
Relapses were 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 Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids.
Time frame: Baseline to Week 96
Change From Baseline in the Degree of Disability
The Expanded Disability Status Scale (EDSS) measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Time frame: Baseline to Week 96
Number of Participants Experiencing Disability Progression
Measured by at least a 1.0-point increase on the EDSS from baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks.
Time frame: Baseline to Week 96
| Milestone | Dimethyl Fumarate |
|---|---|
| Started | 20 |
| Completed | 17 |
| Not completed | 3 |
| Withdrew: Other | 1 |
| Withdrew: Investigator decision | 2 |
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.
| participants | Dimethyl Fumarate |
|---|---|
| AE | 18 |
| SAE | 2 |
An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment.
| participants | Dimethyl Fumarate |
|---|---|
| Number of Participants Discontinuing Treatment Due to an Adverse Event | 0 |
T2 hyperintense lesions were measured by MRI brain scans.
| Participants | Dimethyl Fumarate |
|---|---|
| 0 lesions | 12 |
| 1 lesion | 2 |
| 2 lesions | 1 |
| 3 lesions | 1 |
| 4 lesions | 0 |
| 5 or more lesions | 1 |
T2 hyperintense lesions were measured by MRI brain scans.
| Participants | Dimethyl Fumarate |
|---|---|
| 0 lesions | 8 |
| 1 lesion | 1 |
| 2 lesions | 1 |
| 3 lesions | 0 |
| 4 lesions | 0 |
| 5 or more lesions | 0 |
Relapses were 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 Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids. The ARR was calculated as the total number of relapses that occurred during the previous 12 months and during the 120 weeks on treatment for participants in Study 109MS202 that continued into Study 109MS311, divided by the total number of person-years followed prior to the study and by the total number of person-years followed during the study, respectively.
| relapses per person-years | Dimethyl Fumarate |
|---|---|
| Average Annualized Relapse Rate (ARR) | 0.1 |
Relapses were 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 Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids.
| percentage of participants | Dimethyl Fumarate |
|---|---|
| Percentage of Participants Experiencing One or More Relapses | 10 |
The Expanded Disability Status Scale (EDSS) measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
| score on a scale | Dimethyl Fumarate |
|---|---|
| Baseline | 1.00 ± 1.026 |
| Change from Baseline at Week 12 | 0.15 ± 0.718 |
| Change from Baseline at Week 24 | 0.29 ± 0.508 |
| Change from Baseline at Week 36 | 0.27 ± 0.832 |
| Change from Baseline at Week 48 | 0.50 ± 0.791 |
| Change from Baseline at Week 72 | 0.71 ± 1.010 |
| Change from Baseline at Week 96 | 0.21 ± 0.964 |
Measured by at least a 1.0-point increase on the EDSS from baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks.
| Participants | Dimethyl Fumarate |
|---|---|
| Number of Participants Experiencing Disability Progression | 3 |
Collected over Baseline to Week 96. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BG00012 | 0/20 (0%) | 2/20 (10%) | 18/20 (90%) |
| Event | BG00012 |
|---|---|
| Abdominal painGastrointestinal disorders | 1/20 |
| Multiple sclerosis relapseNervous system disorders | 1/20 |
| Event | BG00012 |
|---|---|
| FlushingVascular disorders | 5/20 |
| Multiple sclerosis relapseNervous system disorders | 4/20 |
| Abdominal painGastrointestinal disorders | 3/20 |
| Upper respiratory tract infectionInfections and infestations | 3/20 |
| Viral upper respiratory tract infectionInfections and infestations | 3/20 |
| HeadacheNervous system disorders | 3/20 |
| DysmenorrhoeaReproductive system and breast disorders | 3/20 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/20 |
| VertigoEar and labyrinth disorders | 2/20 |
| Abdominal pain upperGastrointestinal disorders | 2/20 |
| Age, Categorical(Participants) | Dimethyl Fumarate |
|---|---|
| <=18 years | 14 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Age, Continuous(years) | Dimethyl Fumarate |
|---|---|
| Mean | 16.7 ± 1.31 |
| Sex: Female, Male(Participants) | Dimethyl Fumarate |
|---|---|
| Female | 13 |
| Male | 7 |
| Race/Ethnicity, Customized(participants) | Dimethyl Fumarate |
|---|---|
| Asian | 1 |
| Black or African American | 0 |
| White | 5 |
| Not Reported Due to Confidentiality Regulations | 13 |
| Other | 1 |
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