Phase 3
Completed N=173
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate
Healthy
Source: ClinicalTrials.gov NCT01568112 ↗
Enrolled (actual)
173
Serious AEs
0.6%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) — 41; 91; 81; 98 percentage of participants
◆ Published Evidence
Established
38citations · ~3 / year
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate.
Summary
The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.
Linked Publications
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Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) |
41; 91; 81; 98; 27; 86 | — |
| PRIMARY Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS |
41; 86; 72; 98; 25; 81 | — |
| PRIMARY Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS |
24; 86; 72; 85; 15; 78 | — |
| PRIMARY Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS |
1.2; 4.4; 2.4; 5.6; 0.7; 3.8 | — |
| PRIMARY Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS |
0.9; 3.8; 3.3; 3.1; 0.4; 3.6 | — |
| PRIMARY Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS) |
43; 86; 74; 93 | — |
| PRIMARY Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS |
41; 84; 62; 90 | — |
| PRIMARY Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS |
24; 86; 67; 85 | — |
| PRIMARY Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS) |
73; 81; 81; 86 | — |
| PRIMARY Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS |
66; 81; 79; 79 | — |
| PRIMARY Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS |
41; 59; 53; 61 | — |
| PRIMARY Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS |
0.7; 1.6; 1.6; 1.5; 1.0; 1.8 | — |
| PRIMARY Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS |
0.4; 0.9; 0.8; 0.9; 1.0; 1.4 | — |
| PRIMARY Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) |
59; 70; 79; 79 | — |
| PRIMARY Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) |
57; 65; 67; 71 | — |
| PRIMARY Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) |
34; 59; 50; 58 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) |
24; 24; 26; 26; 10; 13 | — |
| SECONDARY Clinical Laboratory Shifts From Baseline in Reported Values: Hematology |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry |
0; 0; 0; 0; 1; 2 | — |
| SECONDARY Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Vital Signs |
0; 0; 0; 0; 8; 10 | — |
| SECONDARY Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results |
2; 3; 2; 4; 0; 0 | — |
| SECONDARY Duration of Flushing Events During the Overall Treatment Period, Based on MFSS |
98.4; 63.2; 69.8; 68.9 | — |
| SECONDARY Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS |
117.6; 67.6; 89.8; 69.2 | — |
| SECONDARY Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS |
113.2; 55.7; 73.2; 56.0 | — |
| SECONDARY Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS |
9.74; 7.05; 10.01; 2.98; 5.57; 2.92 | — |
| SECONDARY Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS |
10.47; 7.23; 11.18; 2.86; 5.20; 2.53 | — |
| SECONDARY Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS |
3.96; 4.34; 2.66; 2.34; 4.50; 6.62 | — |
Eligibility Criteria
Key Inclusion Criteria
- Must give written informed consent and any authorizations required by local law
- Must have a body mass index (BMI) of between 18.0 to 34.0 kg/m^2,inclusive.
- Ability to complete the tolerability scales by accurately using the hand-held subject reporting device
- Subjects of childbearing potential must be willing to practice effective contraception
Key Exclusion Criteria
- History of clinically significant diseases
- History of severe allergic or anaphylactic reactions
- Intolerance to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
- Diarrhea, constipation, abdominal pain, flushing or nausea within 28 days prior to Day 1
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01568112) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.