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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001294-16 | EudraCT Number |
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| Name | Class |
|---|---|
| Alkermes, Inc. | INDUSTRY |
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The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 8700 | Experimental | Oral capsules, administered orally twice daily. |
|
| Dimethyl Fumarate | Active Comparator | Oral capsules, administered orally twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 8700 | Drug | Administered as specified in the treatment arm. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. | End of treatment (up to Week 6) for both Parts A and B |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. |
Not provided
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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Cullman | Alabama | 35058 | United States | ||
| Alkermes Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38878121 | Derived | Bowen JD, Stulc J, Hunter SF, Chen H, Lewin JB, Scaramozza M, Bozin I, Then Bergh F. Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: NEDA-3 After Re-Baselining in the Phase 3 EVOLVE-MS-1 Study. Adv Ther. 2024 Aug;41(8):3396-3406. doi: 10.1007/s12325-024-02901-1. Epub 2024 Jun 15. | |
| 33796143 | Derived |
Not provided
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A total of 506 participants with relapsing remitting multiple-sclerosis were enrolled in this study. Of which 504 participants received study drug and randomized in Parts A and B of the study (253 participants in ALKS 8700 group and 251 in Dimethyl Fumarate group). A total of 478 participants completed the study.
Participants were enrolled at 70 investigative sites in the United States (US), Germany, and Poland from March 15, 2017 to June 27, 2019.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ALKS 8700 | Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5. |
| FG001 | Dimethyl Fumarate (DMF) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2016 | Jun 1, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dimethyl Fumarate |
| Drug |
Administered as specified in the treatment arm. |
|
|
| End of treatment (up to Week 6) for Part B |
| Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. | End of treatment (up to Week 6) for both Parts A and B |
| Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. | End of treatment (up to Week 6) for both Parts A and B |
| Number of Days With a Global GI Symptom and Impact Scale (GGISIS) Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B | GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries. | End of treatment (up to Week 6) for both Parts A and B |
| Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B | GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries. | End of treatment (up to Week 6) for both Parts A and B |
| Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B | GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries. | End of treatment (up to Week 6) for both Parts A and B |
| Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. Scores were averaged for 5-week treatment period. | End of treatment (up to Week 6) for both Parts A and B |
| Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | End of study (up to Week 10) |
| Phoenix |
| Arizona |
| 85004 |
| United States |
| Alkermes Investigational Site | Tucson | Arizona | 85704 | United States |
| Alkermes Investigational Site | Long Beach | California | 90806 | United States |
| Alkermes Investigational Site | San Diego | California | 92103 | United States |
| Alkermes Investigational Site | Basalt | Colorado | 81621 | United States |
| Alkermes Investigational Site | Centennial | Colorado | 80112 | United States |
| Alkermes Investigational Site | Denver | Colorado | 80209 | United States |
| Alkermes Investigational Site | Middlebury | Connecticut | 06762 | United States |
| Alkermes Investigational Site | Stamford | Connecticut | 06905 | United States |
| Alkermes Investigational Site | Washington D.C. | District of Columbia | 20007 | United States |
| Alkermes Investigational Site | Atlantis | Florida | 33462 | United States |
| Alkermes Investigational Site | Bradenton | Florida | 34209 | United States |
| Alkermes Investigational Site | Maitland | Florida | 32751 | United States |
| Alkermes Investigational Site | Naples | Florida | 34105 | United States |
| Alkermes Investigational Site | Ormond Beach | Florida | 32174 | United States |
| Alkermes Investigational Site | Sarasota | Florida | 34233 | United States |
| Alkermes Investigational Site | Tampa | Florida | 33634 | United States |
| Alkermes Investigational Site | Vero Beach | Florida | 32960 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30312 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30327 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30342 | United States |
| Alkermes Investigational Site | Columbus | Georgia | 31904 | United States |
| Alkermes Investigational Site | Evanston | Illinois | 60201 | United States |
| Alkermes Investigational Site | Des Moines | Iowa | 50314 | United States |
| Alkermes Investigational Site | Lenexa | Kansas | 66214 | United States |
| Alkermes Investigational Site | Alexandria | Louisiana | 71301 | United States |
| Alkermes Investigational Site | Detroit | Michigan | 48202 | United States |
| Alkermes Investigational Site | Golden Valley | Minnesota | 55422 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63104 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63110 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63131 | United States |
| Alkermes Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| Alkermes Investigational Site | Patchogue | New York | 11772 | United States |
| Alkermes Investigational Site | Stony Brook | New York | 11794 | United States |
| Alkermes Investigational Site | Syracuse | New York | 13210 | United States |
| Alkermes Investigational Site | Charlotte | North Carolina | 28203 | United States |
| Alkermes Investigational Site | Greensboro | North Carolina | 27405 | United States |
| Alkermes Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Alkermes Investigational Site | Canton | Ohio | 44718 | United States |
| Alkermes Investigational Site | Columbus | Ohio | 43221 | United States |
| Alkermes Investigational Site | Dayton | Ohio | 45417 | United States |
| Alkermes Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| Alkermes Investigational Site | Charleston | South Carolina | 29406 | United States |
| Alkermes Investigational Site | Greer | South Carolina | 29650 | United States |
| Alkermes Investigational Site | Old Point Station | South Carolina | 29707 | United States |
| Alkermes Investigational Site | Spartanburg | South Carolina | 29307 | United States |
| Alkermes Investigational Site | Franklin | Tennessee | 37064 | United States |
| Alkermes Investigational Site | Knoxville | Tennessee | 37922 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75231 | United States |
| Alkermes Investigational Site | Houston | Texas | 77030 | United States |
| Alkermes Investigational Site | Houston | Texas | 77074 | United States |
| Alkermes Investigational Site | Newport News | Virginia | 23601 | United States |
| Alkermes Investigational Site | Richmond | Virginia | 23226 | United States |
| Alkermes Investigational Site | Seattle | Washington | 98101 | United States |
| Alkermes Investigational Site | Seattle | Washington | 98122 | United States |
| Alkermes Investigational Site | Seattle | Washington | 98133 | United States |
| Alkermes Investigational Site | Dresden | Germany |
| Alkermes Investigational Site | Leipzig | Germany |
| Alkermes Investigational Site | Ulm | Germany |
| Alkermes Investigational Site | Westerstede | Germany |
| Alkermes Investigational Site | Gdansk | 80-803 | Poland |
| Alkermes Investigational Site | Katowice | 40-123 | Poland |
| Alkermes Investigational Site | Kielce | 25-726 | Poland |
| Alkermes Investigational Site | Lodz | 90-324 | Poland |
| Alkermes Investigational Site | Plewiska | 62-064 | Poland |
| Alkermes Investigational Site | Szczecin | 70-111 | Poland |
| Wundes A, Wray S, Gold R, Singer BA, Jasinska E, Ziemssen T, de Seze J, Repovic P, Chen H, Hanna J, Messer J, Miller C, Naismith RT. Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study. Ther Adv Neurol Disord. 2021 Mar 19;14:1756286421993999. doi: 10.1177/1756286421993999. eCollection 2021. |
| 31953790 | Derived | Naismith RT, Wundes A, Ziemssen T, Jasinska E, Freedman MS, Lembo AJ, Selmaj K, Bidollari I, Chen H, Hanna J, Leigh-Pemberton R, Lopez-Bresnahan M, Lyons J, Miller C, Rezendes D, Wolinsky JS; EVOLVE-MS-2 Study Group. Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study. CNS Drugs. 2020 Feb;34(2):185-196. doi: 10.1007/s40263-020-00700-0. |
Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5. |
|
| Safety Population | All enrolled participants who received at least one dose of study drug. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety population included all enrolled participants who had received at least one dose of study drug during the double-blind Treatment Period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ALKS 8700 | Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5. |
| BG001 | Dimethyl Fumarate (DMF) | Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. | The full analysis set (FAS) population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date. | Posted | Mean | Standard Deviation | days | End of treatment (up to Week 6) for both Parts A and B |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. | The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | days | End of treatment (up to Week 6) for Part B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. | The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date. | Posted | Mean | Standard Deviation | days | End of treatment (up to Week 6) for both Parts A and B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. | The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date. | Posted | Mean | Standard Deviation | days | End of treatment (up to Week 6) for both Parts A and B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days With a Global GI Symptom and Impact Scale (GGISIS) Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B | GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries. | The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as GGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | days | End of treatment (up to Week 6) for both Parts A and B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B | GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries. | The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as GGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | days | End of treatment (up to Week 6) for both Parts A and B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B | GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries. | The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as GGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | days | End of treatment (up to Week 6) for both Parts A and B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. Scores were averaged for 5-week treatment period. | The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date. | Posted | Mean | Standard Deviation | score on a scale | End of treatment (up to Week 6) for both Parts A and B |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | The Safety population included all enrolled participants who had received at least one dose of study drug during the double-blind Treatment Period. | Posted | Number | participants | End of study (up to Week 10) |
|
End of study (up to Week 10)
The Safety population included all enrolled participants who had received at least one dose of study drug during the double-blind Treatment Period.
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 | ALKS 8700 | Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5. | 0 | 253 | 4 | 253 | 175 | 253 |
| EG001 | Dimethyl Fumarate (DMF) | Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5. | 0 | 251 | 3 | 251 | 191 | 251 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Urine albumin/creatinine ratio increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 20.1 | 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 | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2019 | Jun 1, 2020 | SAP_001.pdf |
Not provided
| 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 |
| 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
| Male |
|
| Hispanic or Latino |
|
| Black or African American |
|
| Other |
|
| Asian |
|
| Multiple races |
|
| Native Hawaiian or Other Pacific Islander |
|
| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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