Page last updated: 2024-10-23

aspirin and Acute Relapsing Multiple Sclerosis

aspirin has been researched along with Acute Relapsing Multiple Sclerosis in 3 studies

Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.
acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity.

Research Excerpts

Excerpt	Relevance	Reference
" The purpose of the present study was to examine 2 potential mitigation strategies for flushing and gastrointestinal (GI) events associated with DMF treatment: aspirin (ASA) 325 mg pretreatment for flushing, and slow dose titration of DMF for flushing and GI events."	7.81	Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. ( Kurukulasuriya, NC; Li, J; O'Gorman, J; Phillips, G; Russell, HK; Viglietta, V, 2015)
" The purpose of the present study was to examine 2 potential mitigation strategies for flushing and gastrointestinal (GI) events associated with DMF treatment: aspirin (ASA) 325 mg pretreatment for flushing, and slow dose titration of DMF for flushing and GI events."	3.81	Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. ( Kurukulasuriya, NC; Li, J; O'Gorman, J; Phillips, G; Russell, HK; Viglietta, V, 2015)
"Aspirin treatment prevented the symptoms."	2.72	Premenstrual multiple sclerosis pseudoexacerbations: Role of body temperature and prevention with aspirin. ( Rodriguez, M; Wingerchuk, DM, 2006)

Research

Studies (3)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (33.33)	29.6817
2010's	2 (66.67)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Leavitt, VM	1
Blanchard, AR	1
Guo, CY	1
Gelernt, E	1
Sumowski, JF	1
Stein, J	1
O'Gorman, J	1
Russell, HK	1
Li, J	1
Phillips, G	1
Kurukulasuriya, NC	1
Viglietta, V	1
Wingerchuk, DM	1
Rodriguez, M	1

Clinical Trials (2)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)[NCT03824938]	Phase 3	60 participants (Actual)	Interventional	2019-04-30	Completed
A Randomized, Double-Blind, Phase 3b Study to Evaluate Effects of Aspirin or Dose Titration on Flushing and Gastrointestinal Events Following Oral Administration of BG00012 Dosed at 240 mg BID[NCT01568112]	Phase 3	173 participants (Actual)	Interventional	2012-04-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Exercise-induced Body Temperature Change

Change in body temperature from pre- to post- maximal exercise test. (NCT03824938)
Timeframe: from start of exercise test until self-reported exhaustion, up to 30 minutes

Intervention	degrees Fahrenheit (Mean)
Placebo	0.68
Aspirin	0.006
Acetaminophen	0.31

Time-to-exhaustion

Duration of time exercising before reaching peak exertion, defined as cadence drop below 40 revolutions per minute (RPM) for >/= 5 seconds, or patient reaches volitional exhaustion in accordance with American Thoracic Society standard test termination criteria. (NCT03824938)
Timeframe: from start of exercise test until self-reported exhaustion, up to 30 minutes

Intervention	seconds (Mean)
Placebo	551.7
Aspirin	331.6
Acetaminophen	578.2

Duration of Flushing Events During the Overall Treatment Period, Based on MFSS

For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. (NCT01568112)
Timeframe: Day 1 to Week 8

Intervention	minutes (Mean)
Placebo	98.4
BG00012	63.2
BG00012 + ASA	69.8
BG00012 Slow Titration	68.9

Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS

Intervention	minutes (Mean)
Placebo	117.6
BG00012	67.6
BG00012 + ASA	89.8
BG00012 Slow Titration	69.2

Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS

Intervention	minutes (Mean)
Placebo	113.2
BG00012	55.7
BG00012 + ASA	73.2
BG00012 Slow Titration	56.0

Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)

The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. (NCT01568112)
Timeframe: Day 1 to Week 8

Intervention	percentage of participants (Number)
Placebo	73
BG00012	81
BG00012 + ASA	81
BG00012 Slow Titration	86

Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)

The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. (NCT01568112)
Timeframe: Day 1 to Week 8

Intervention	percentage of participants (Number)
Placebo	59
BG00012	70
BG00012 + ASA	79
BG00012 Slow Titration	79

Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)

Intervention	percentage of participants (Number)
Placebo	57
BG00012	65
BG00012 + ASA	67
BG00012 Slow Titration	71

Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS

Intervention	percentage of participants (Number)
Placebo	66
BG00012	81
BG00012 + ASA	79
BG00012 Slow Titration	79

Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)

Intervention	percentage of participants (Number)
Placebo	34
BG00012	59
BG00012 + ASA	50
BG00012 Slow Titration	58

Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS

Intervention	percentage of participants (Number)
Placebo	41
BG00012	59
BG00012 + ASA	53
BG00012 Slow Titration	61

Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)

Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1. (NCT01568112)
Timeframe: Day 2 to Week 8

Intervention	percentage of participants (Number)
Placebo	43
BG00012	86
BG00012 + ASA	74
BG00012 Slow Titration	93

Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS

Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1. (NCT01568112)
Timeframe: Day 2 to Week 4

Intervention	percentage of participants (Number)
Placebo	41
BG00012	84
BG00012 + ASA	62
BG00012 Slow Titration	90

Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS

Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score. (NCT01568112)
Timeframe: Week 5 to Week 8

Intervention	percentage of participants (Number)
Placebo	24
BG00012	86
BG00012 + ASA	67
BG00012 Slow Titration	85

Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry

Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen. (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	participants (Number)
	ALP: shift to high; n=44, 42, 43, 42	ALT: shift to high; n=44, 42, 43, 42	AST: shift to high; n=44, 43, 43, 41	GGT: shift to high; n=44, 41, 43, 42	LDH: shift to low; n=44, 43, 43, 42	LDH: shift to high; n=44, 43, 43, 42	Total bilirubin: shift to high; n=44, 42, 42, 40	BUN: shift to low; n=44, 43, 43, 42	BUN: shift to high; n=44, 43, 41, 42	Creatinine: shift to low; n=44, 43, 43, 42	Creatinine: shift to high; n=44, 43, 43, 42	Uric Acid: shift to low; n=44, 43, 43, 42	Uric Acid: shift to high; n=44, 43, 43, 42	Sodium: shift to low; n=44, 43, 43, 42	Sodium: shift to high; n=44, 43, 43, 42	Potassium: shift to low: n=44, 43, 43, 42	Potassium: shift to high: n=44, 42, 42, 41	Chloride: shift to low; n=44, 43, 43, 42	Chloride: shift to high; n=44, 43, 43, 42	Bicarbonate: shift to low; n=44, 43, 43, 42	Bicarbonate: shift to high; n=44, 43, 43, 42	Calcium: shift to low; n=44, 42, 43, 42	Calcium: shift to high; n=44, 43, 43, 42	Glucose: shift to low; n=43, 43, 41, 41	Glucose: shift to high; n=44, 43, 43, 42	Magnesium: shift to low; n=44, 43, 43, 42	Magnesium: shift to high; n=44, 43, 43, 42	Phosphorus: shift to low; n=44, 43, 43, 41	Phosphorus: shift to high; n=44, 43, 43, 42	Albumin: shift to low; n=44, 43, 43, 42	Albumin: shift to high; n=44, 43, 43, 42	Direct bilirubin: shift to high; n=44, 43, 43, 40	Total protein: shift to low; n=44, 41, 43, 41	Total protein: shift to high; n=44, 43, 43, 42
BG00012	0	2	3	0	0	0	1	0	0	1	0	0	0	0	0	0	1	0	0	1	0	0	0	1	0	0	0	1	0	0	0	0	0	0
BG00012 + ASA	0	5	4	2	0	1	0	0	1	0	0	0	0	0	1	0	1	0	0	1	0	1	0	1	0	0	0	0	0	0	0	0	1	0
BG00012 Slow Titration	0	2	1	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	1	0	0	1	0	0	0	0	0
Placebo	0	1	2	0	0	0	1	0	1	0	0	0	0	1	0	0	1	1	0	1	0	0	0	3	1	1	0	0	0	0	0	0	0	0

Clinical Laboratory Shifts From Baseline in Reported Values: Hematology

Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	participants (Number)
	White blood cells: shift to low; n=43, 43, 43, 41	White blood cells: shift to high; n=44, 43, 43, 42	Neutrophils abs: shift to low; n=42, 42, 42, 41	Neutrophils abs: shift to high; n=44, 43, 43, 42	Lymphocytes abs: shift to low; n=43, 43, 43, 41	Lymphocytes abs: shift to high; n=44, 43, 42, 42	Monocytes abs: shift to low; n=44, 43, 43, 42	Monocytes abs: shift to high; n=44, 43, 43, 42	Eosinophils abs: shift to low; n=44, 43, 43, 42	Eosinophils abs: shift to high; n=44, 43, 43, 42	Basophils abs: shift to high; n=44, 43, 43, 42	Red blood cells: shift to low; n=44, 43, 43, 40	Red blood cells: shift to high; n=44, 43, 43, 42	Hemoglobin: shift to low; n=43, 41, 43, 42	Hemoglobin: shift to high; n=44, 43, 43, 42	Hematocrit: shift to low; n=44, 43, 43, 42	Hematocrit: shift to high; n=43, 43, 43, 42	Platelets: shift to low; n=44, 43, 43, 42	Platelets: shift to high; n=44, 41, 43, 42
BG00012	2	0	6	0	5	0	0	0	0	5	1	2	0	3	0	2	0	0	0
BG00012 + ASA	0	1	2	0	2	0	0	0	0	6	1	0	0	1	0	0	0	0	1
BG00012 Slow Titration	0	0	2	1	3	0	0	0	0	6	0	0	0	0	0	0	1	0	1
Placebo	0	0	3	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0

Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis

Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells. (NCT01568112)
Timeframe: Day 1 to Week 8

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Intervention	participants (Number)
	Specific gravity: shift to low; n=44, 43, 43, 42	Specific gravity: shift to high; n=44, 42, 43, 42	pH: shift to low; n=44, 43, 43, 42	pH: shift to high; n=44, 43, 43, 42	Blood: shift to positive; n=42, 39, 39, 42	Color: shift to positive; n=41, 43, 41, 39	Glucose: shift to positive; n=44, 43, 43, 41	Ketones: shift to positive; n=44, 43, 43, 42	Protein: shift to positive; n=44, 41, 43, 41	Microscopic RBC; n=44, 40, 40, 41	Microscopic WBC; n=43, 40, 41, 42
BG00012	0	0	0	0	6	1	2	7	1	4	9
BG00012 + ASA	0	2	0	0	1	4	1	9	1	1	3
BG00012 Slow Titration	0	0	0	0	2	5	0	6	1	2	3
Placebo	0	0	0	0	3	2	0	1	0	3	4

Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS

Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	hours (Mean)
	Nausea; n=12, 21, 21, 22	Diarrhea; n=20, 20 17, 15	Upper abdominal pain; n=17, 14, 19, 19	Lower abdominal pain; n=12, 19, 17, 16	Vomiting; n=3, 3, 3, 2	Indigestion; n=12, 13, 12, 12	Constipation; n=6, 8, 13, 11	Bloating; n=14, 14, 21, 12	Flatulence; n=23, 20, 22, 20
BG00012	7.05	2.92	6.67	13.93	10.08	16.49	28.20	16.91	9.06
BG00012 + ASA	10.01	14.66	15.88	10.84	1.88	3.80	14.26	9.68	68.93
BG00012 Slow Titration	2.98	4.97	3.83	7.75	0.75	4.91	20.90	77.24	63.84
Placebo	9.74	5.57	19.08	6.65	5.87	4.76	20.49	9.50	16.41

Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS

,,,

Intervention	hours (Mean)
	Nausea; n=10, 18, 18, 20	Diarrhea; n=13, 20, 14, 14	Upper abdominal pain; n=14, 14, 17, 15	Lower abdominal pain; n=9, 18, 14, 13	Vomiting; n=2, 2, 2, 2	Indigestion; n=11, 11, 9, 11	Constipation; n=4, 8, 11, 11	Bloating; n=9, 14, 19, 11	Flatulence; n=21, 17, 22, 19
BG00012	7.23	2.53	6.81	14.20	5.63	29.00	27.61	13.81	9.34
BG00012 + ASA	11.18	16.04	17.65	12.51	2.53	3.93	15.12	11.07	35.86
BG00012 Slow Titration	2.86	4.97	4.31	6.30	0.75	5.05	21.28	95.69	61.13
Placebo	10.47	5.20	21.37	5.40	4.31	5.08	17.05	6.70	12.83

Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS

,,,

Intervention	hours (Mean)
	Nausea; n=4, 9, 6, 9	Diarrhea; n=12, 13, 6, 8	Upper abdominal pain; n=6, 5, 5, 5	Lower abdominal pain; n=7, 5, 5, 9	Vomiting; n=1, 1, 1, 0	Indigestion; n=6, 7, 7, 5	Constipation; n=5, 2, 4, 4	Bloating; n=7, 8, 7, 8	Flatulence; n=9, 13, 7, 10
BG00012	4.34	6.62	1.12	3.98	19.00	2.57	15.47	18.52	7.21
BG00012 + ASA	2.66	7.05	1.86	2.84	0.58	5.02	21.30	4.16	105.86
BG00012 Slow Titration	2.34	2.14	1.73	22.54	NA	1.63	18.24	85.64	18.48
Placebo	3.96	4.50	5.29	6.63	9.00	2.43	23.35	12.49	44.67

Number of Participants With Abnormalities in Vital Signs

↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	participants (Number)
	Temperature >38°C + ↑ from BL of ≥1°C	Pulse >120 bpm or ↑ from BL of >20 bpm	Pulse <50 bpm or ↓ from BL of >20 bpm	SBP >180 mm Hg or ↑ from BL of >40 mm Hg	SBP <90 mm Hg or ↓ from BL of >30 mm Hg	DBP >105 mm Hg or ↑ from BL of >30 mm Hg	DBP <50 mm Hg or ↓ from BL of >20 mm Hg	Respiration rate >25 b/m or ↑ from BL of ≥50%	Respiration rate 10 b/m or ↓ from BL of ≥50%
BG00012	0	10	4	0	2	0	3	2	0
BG00012 + ASA	0	20	3	0	1	0	0	3	0
BG00012 Slow Titration	0	17	4	0	1	0	1	3	0
Placebo	0	8	11	1	1	0	1	1	0

Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results

Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.' (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	participants (Number)
	Shift to abnormal, not adverse event	Shift to abnormal, adverse event
BG00012	3	0
BG00012 + ASA	2	0
BG00012 Slow Titration	4	0
Placebo	2	0

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (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 subject at immediate risk of death; 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 subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened. (NCT01568112)
Timeframe: Day 1 up to end of Safety Follow-up (9 weeks)

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Intervention	participants (Number)
	Any event	Moderate or severe event	Severe event	Related event	Serious event	Discontinuation of treatment due to an event	Withdrawal from study due to an event
BG00012	24	13	4	17	1	4	4
BG00012 + ASA	26	12	4	16	0	6	6
BG00012 Slow Titration	26	11	1	18	0	3	3
Placebo	24	10	0	8	0	2	2

Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)

Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Day 1 to Week 8

,,,

Intervention	percentage of participants (Number)
	Overall flushing events	Overall redness events	Overall warmth events	Overall tingling events	Overall itching events
BG00012	91	86	93	88	86
BG00012 + ASA	81	77	84	67	72
BG00012 Slow Titration	98	90	98	86	98
Placebo	41	27	41	23	20

Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS

Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Week 1 to Week 4

,,,

Intervention	percentage of participants (Number)
	Overall flushing events	Overall redness events	Overall warmth events	Overall tingling events	Overall itching events
BG00012	86	81	88	84	77
BG00012 + ASA	72	63	67	51	56
BG00012 Slow Titration	98	88	95	83	95
Placebo	41	25	41	23	16

Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS

,,,

Intervention	percentage of participants (Number)
	Overall flushing events	Overall redness events	Overall warmth events	Overall tingling events	Overall itching events
BG00012	86	78	86	81	78
BG00012 + ASA	72	64	75	64	58
BG00012 Slow Titration	85	79	82	70	61
Placebo	24	15	17	15	22

Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS

Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. (NCT01568112)
Timeframe: Day 1 to Week 4

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Intervention	units on a scale (Mean)
	Nausea	Diarrhea	Upper abdominal pain	Lower abdominal pain	Vomiting	Indigestion	Constipation	Bloating	Flatulence
BG00012	1.6	1.8	1.1	1.4	0.3	0.9	0.9	1.1	1.3
BG00012 + ASA	1.6	1.5	1.7	1.3	0.3	0.6	0.6	1.3	1.4
BG00012 Slow Titration	1.5	1.0	1.4	1.2	0.2	0.9	0.9	1.0	1.6
Placebo	0.7	1.0	0.8	0.5	0.2	0.7	0.4	0.5	1.3

Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS

,,,

Intervention	units on a scale (Mean)
	Nausea	Diarrhea	Upper abdominal pain	Lower abdominal pain	Vomiting	Indigestion	Constipation	Bloating	Flatulence
BG00012	0.9	1.4	0.5	0.4	0.1	0.5	0.1	0.7	1.2
BG00012 + ASA	0.8	0.8	0.4	0.5	0.1	0.5	0.6	0.7	0.4
BG00012 Slow Titration	0.9	0.7	0.6	0.9	0.0	0.4	0.3	0.8	0.9
Placebo	0.4	1.0	0.6	0.6	0.2	0.4	0.4	0.5	0.8

Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS

Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Day 1 to Week 4

,,,

Intervention	units on a scale (Mean)
	Overall flushing	Redness	Warmth	Tingling	Itching
BG00012	4.4	3.8	4.0	3.4	3.2
BG00012 + ASA	2.4	1.6	2.3	1.6	1.3
BG00012 Slow Titration	5.6	5.1	5.2	4.0	4.3
Placebo	1.2	0.7	1.2	0.5	0.5

Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS

Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Week 5 to Week 8

,,,

Intervention	units on a scale (Mean)
	Overall flushing	Redness	Warmth	Tingling	Itching
BG00012	3.8	3.6	3.9	3.3	3.1
BG00012 + ASA	3.3	2.9	3.1	2.3	2.3
BG00012 Slow Titration	3.1	2.9	2.9	2.2	1.8
Placebo	0.9	0.4	0.8	0.3	0.7

Trials

2 trials available for aspirin and Acute Relapsing Multiple Sclerosis

Article	Year
Aspirin is an effective pretreatment for exercise in multiple sclerosis: A double-blind randomized controlled pilot trial. Multiple sclerosis (Houndmills, Basingstoke, England), 2018, Volume: 24, Issue:11 Topics: Adult; Antipyretics; Aspirin; Body Temperature; Double-Blind Method; Exercise; Female; Humans; Male;	2018
Premenstrual multiple sclerosis pseudoexacerbations: Role of body temperature and prevention with aspirin. Archives of neurology, 2006, Volume: 63, Issue:7 Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Body Temperature; Cir	2006

Other Studies

1 other study available for aspirin and Acute Relapsing Multiple Sclerosis

Article	Year
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. Clinical therapeutics, 2015, Jul-01, Volume: 37, Issue:7 Topics: Abdominal Pain; Adult; Aspirin; Constipation; Delayed-Action Preparations; Diarrhea; Dimethyl Fumara	2015