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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001025-53 | EudraCT Number | ||
| DEN-BGT-13-10413 | Other Identifier | Biogen |
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The study was withdrawn for business reasons. The decision to stop the TECNERGY study was not a result of any safety or efficacy concerns.
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The primary objective of this study is to determine whether dimethyl fumarate (DMF) taken over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are: To investigate changes from Baseline in FSMC and fatigue severity (Fatigue Severity Scale [FSS]) at 1, 3, 6, 9, and 12 months in participants receiving DMF; To assess the impact of DMF on patient-reported outcomes (PROs), including work productivity (Work Productivity and Activity Impairment-Multiple Sclerosis questionnaire [WPAI-MS]), health-related quality of life (Short Form Health Survey [SF-12]), depression (Beck Depression Inventory-Fast Screen [BDI-FS]), and sleepiness (Epworth Sleepiness Scale [ESS]) at 6 and 12 months in participants receiving DMF; To examine whether an association exists between fatigue and baseline demographics (e.g., age and sex) and disease characteristics (e.g., disease duration, baseline disease activity, treatment history, expanded disability status scale [EDSS] score, and PROs); To assess any changes in fatigue-related medication use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dimethyl fumarate | Experimental | DMF at a dose of 120 mg twice a day (BID) for the first 7 days and 240 mg BID for the remainder of study period (up to 12 months) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | Administered as specified in the treatment arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in MS-related fatigue as assessed by FSMC at 12 months in participants receiving DMF | FSMC is a 20-item questionnaire and produces a score between 1 and 5 for each scored question (ranging from "does not apply at all" to "applies completely"). Items are summed to generate a total score and transformed to a scale with a range of 20 to 100, where higher scores indicate higher levels of fatigue | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in fatigue as assessed by FSMC in participants receiving DMF | Baseline and 1, 3, 6, 9 and 12 months | |
| Mean change from baseline in fatigue as assessed by FSS in participants receiving DMF | The Fatigue Severity Scale (FSS) is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. FSS consists of answering a 9-item questionnaire that requires the participant to rate his or her own level of fatigue. Each question produces a score between 1 to 7. The scoring is done by calculating the average response to the questions. Participants with depression alone score about 4.5. But people with fatigue related to MS average about 6.5 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion Criteria May Apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Baseline and 1, 3, 6, 9 and 12 months |
| Mean change from baseline in work productivity as assessed by WPAI-MS, in participants receiving DMF | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity | Baseline and 6, 12 months |
| Mean change from baseline in quality of life as assessed by SF-12 in participants receiving DMF | The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health | Baseline and 6, 12 months |
| Mean change from baseline in depression as assessed by BDI-FS in participants receiving DMF | BDI-FS is a self-report inventory for measuring the severity of depression on a 7-item questionnaire. Each question is rated on a 4-point scale (0 - 3) to assess frequency, over the past two weeks, of feelings of sadness, pessimism (hopelessness), sense of failure, loss of a sense of pleasure, loss of self-confidence, self-blame, and suicidal ideation. The total ESS score is the sum of 8 item-scores and can range between 0 and 21, where higher scores indicate higher levels of depression | Baseline and 6, 12 months |
| Mean change from baseline in sleepiness assessed by ESS in participants receiving DMF | The ESS is a self-administered 8-item questionnaire with that provides a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. Each question is rated on a 4-point scale (0 - 3), their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily lives, although not necessarily every day. The total ESS score is the sum of 8 item-scores and can range between 0 and 24, where higher scores indicate higher levels of a person's level of daytime sleepiness | Baseline and 6, 12 months |
| Change in MS-related fatigue (FSMC) status | Improved (> 4.5 increase), Stable (within ±4.5), and Worsened (> 4.5 decrease) | Baseline and up to 12 months |
| Correlation of fatigue with baseline demographics and disease characteristics | Baseline and up to 12 months |
| Proportion of participants with reduced dose or discontinuation of fatigue-related medications | 6 and 12 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |