Page last updated: 2024-10-22

acetaminophen and Multiple Sclerosis, Relapsing-Remitting

acetaminophen has been researched along with Multiple Sclerosis, Relapsing-Remitting in 5 studies

Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group.

Multiple Sclerosis, Relapsing-Remitting: The most common clinical variant of MULTIPLE SCLEROSIS, characterized by recurrent acute exacerbations of neurologic dysfunction followed by partial or complete recovery. Common clinical manifestations include loss of visual (see OPTIC NEURITIS), motor, sensory, or bladder function. Acute episodes of demyelination may occur at any site in the central nervous system, and commonly involve the optic nerves, spinal cord, brain stem, and cerebellum. (Adams et al., Principles of Neurology, 6th ed, pp903-914)

Research Excerpts

ExcerptRelevanceReference
"Naproxen and ibuprofen were more effective than acetaminophen in minimizing physical side effects of IFN beta-1a."6.71A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis. ( Filipi, M; Healey, K; Leuschen, MP, 2004)
"To assess dose-response effects of the anti-CD20 monoclonal antibody ofatumumab on efficacy and safety outcomes in a phase 2b double-blind study of relapsing forms of multiple sclerosis (RMS)."2.87Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study. ( Austin, DJ; Bar-Or, A; Derosier, FJ; Grove, RA; Kavanagh, ST; Lewis, EW; Lopez, MC; Miller, AE; Sorensen, PS; Tolson, JM; VanMeter, SA, 2018)
"Naproxen and ibuprofen were more effective than acetaminophen in minimizing physical side effects of IFN beta-1a."2.71A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis. ( Filipi, M; Healey, K; Leuschen, MP, 2004)

Research

Studies (5)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's4 (80.00)29.6817
2010's1 (20.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Bar-Or, A1
Grove, RA1
Austin, DJ1
Tolson, JM1
VanMeter, SA1
Lewis, EW1
Derosier, FJ1
Lopez, MC1
Kavanagh, ST1
Miller, AE1
Sorensen, PS1
Río, J1
Nos, C1
Bonaventura, I1
Arroyo, R1
Genis, D1
Sureda, B1
Ara, JR1
Brieva, L1
Martín, J1
Saiz, A1
Sánchez López, F1
Prieto, JM1
Roquer, J1
Dorado, JF1
Montalban, X1
Leuschen, MP1
Filipi, M1
Healey, K1
Brandes, DW1
Bigley, K1
Hornstein, W1
Cohen, H1
Au, W1
Shubin, R1
Reess, J1
Haas, J1
Gabriel, K1
Fuhlrott, A1
Fiola, M1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)[NCT01457924]Phase 2232 participants (Actual)Interventional2011-11-01Completed
Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset[NCT04466150]Phase 430 participants (Anticipated)Interventional2020-08-30Active, not recruiting
A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a[NCT03424733]Phase 450 participants (Anticipated)Interventional2017-09-25Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Cumulative Number of All (New Plus Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12

The cumulative number of all (new plus persistent) GdE T1 lesion at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of all (new plus persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. (NCT01457924)
Timeframe: Week 12

InterventionCumulative number of lesions (Mean)
Placebo/Ofatumumab 3 mg7.4
Ofatumumab 3 mg q12w2.9
Ofatumumab 30 mg q12w4.5
Ofatumumab 60 mg q12w4.0
Ofatumumab 60mg q4w3.1

Cumulative Number of New and Newly Enlarging GdE T2 Lesions at Week 12

The cumulative number of new and newly enlarging GdE T2 lesions (NET2L) at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of NET2L per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. (NCT01457924)
Timeframe: Week 12

InterventionCumulative number of lesions (Mean)
Placebo/Ofatumumab 3 mg3.7
Ofatumumab 3 mg q12w1.2
Ofatumumab 30 mg q12w1.6
Ofatumumab 60 mg q12w1.7
Ofatumumab 60mg q4w0.8

Cumulative Number of New Gadolinium-enhancing (GdE) T1 Lesions at Week 12

The cumulative number of new GdE T1 lesion at Week 12 were analyzed from screening based on magnetic resonance imaging (MRI) brain scans at Weeks 4, 8, and 12. The outcome measure was analyzed using an Emax model adjusting for the presence/absence of GdE lesions on the Screening MRI and assuming the number of new lesions followed a negative binomial distribution. Dose was fitted as a continuous variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE lesions per scan at Week 12 were determined from the model. The all evaluable scans (AES) dataset was used which included all evaluable on-treatment MRI scans for each participant analysed. (NCT01457924)
Timeframe: Week 12

InterventionCumulative number of lesions (Mean)
Placebo/Ofatumumab 3 mg4.2
Ofatumumab 3 mg q12w1.7
Ofatumumab 30 mg q12w2.2
Ofatumumab 60 mg q12w2.2
Ofatumumab 60mg q4w1.2

Cumulative Number of New GdE T1 Lesions at Week 24

The cumulative number of new GdE T1 lesion at Week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE T1 lesions per scan at Week 24 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each participant analyzed. (NCT01457924)
Timeframe: Week 24

InterventionCumulative number of lesions (Mean)
Placebo/Ofatumumab 3 mg5.6
Ofatumumab 3 mg q12w2.2
Ofatumumab 30 mg q12w2.5
Ofatumumab 60 mg q12w2.2
Ofatumumab 60mg q4w1.4

Cumulative Number of Persistent GdE Brain Lesions on T1-weighted MRI at Week 12

The cumulative number of persistent GdE T1 lesions at Week 12 were analyzed from screen based on MRI scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. (NCT01457924)
Timeframe: Week 12

InterventionNumber of lesions per scan (Mean)
Placebo/Ofatumumab 3 mg3.2
Ofatumumab 3 mg q12w1.2
Ofatumumab 30 mg q12w2.3
Ofatumumab 60 mg q12w1.8
Ofatumumab 60mg q4w1.8

Total Volume of All (New and Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12

Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of all (new and persistent) GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of all (new and persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. (NCT01457924)
Timeframe: Week 12

Interventionmm^3 (Mean)
Placebo/Ofatumumab 3 mg1039.6
Ofatumumab 3 mg q12w386.2
Ofatumumab 30 mg q12w886.2
Ofatumumab 60 mg q12w426.5
Ofatumumab 60mg q4w344.4

Total Volume of New and/or Newly Enlarging T2 Lesions at Week 12

Lesion volume is a measure of lesion size determined by a MRI brain scan. T2 lesions, are indicative of brain myelin content.The cumulative volume of new and/or newly enlarging T2 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. (NCT01457924)
Timeframe: Week 12

Interventionmm^3 (Mean)
Placebo/Ofatumumab 3 mg1204.5
Ofatumumab 3 mg q12w279.9
Ofatumumab 30 mg q12w611.3
Ofatumumab 60 mg q12w293.8
Ofatumumab 60mg q4w167.9

Total Volume of New GdE Brain Lesions on T1-weighted MRI at Week 12

Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of new GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of new GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. (NCT01457924)
Timeframe: Week 12

InterventionCubic millimeter (mm^3) (Mean)
Placebo/Ofatumumab 3 mg607.5
Ofatumumab 3 mg q12w226.5
Ofatumumab 30 mg q12w452.9
Ofatumumab 60 mg q12w248.6
Ofatumumab 60mg q4w146.6

Change From Baseline in Brain Volume at Week 24 and Week 48

Brain volume is a measure of brain size determined by a MRI scan. Baseline is defined as the par. last available assessment prior to initiation of the IP (i.e. Screening). Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. (NCT01457924)
Timeframe: Baseline (Week 0), Week 24 and Week 48

,,,,
InterventionCubic centimeters (Mean)
Week 24Week 48
Ofatumumab 3 mg q12w-7.2-12.9
Ofatumumab 30 mg q12w-8.4-5.0
Ofatumumab 60 mg q12w-13.3-7.3
Ofatumumab 60mg q4w-1.4-11.8
Placebo/Ofatumumab 3 mg-13.5-22.0

Cumulative Number of New T1 Hypointense Lesions at Week 24 and Week 48

The cumulative number of new T1 hypointense lesions at week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. (NCT01457924)
Timeframe: Week 24 and Week 48

,,,,
InterventionNumber of lesions (Mean)
Week 24Week 48
Ofatumumab 3 mg q12w0.40.5
Ofatumumab 30 mg q12w0.50.5
Ofatumumab 60 mg q12w0.50.6
Ofatumumab 60mg q4w0.30.3
Placebo/Ofatumumab 3 mg0.40.6

Cumulative Volume of New T1 Hypointense Lesions at Week 24 and Week 48

Lesion volume is a measure of lesion size determined by a MRI brain scan. Baseline is defined as the participant's last available assessment prior to initiation of IP. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. (NCT01457924)
Timeframe: Baseline, Week 24 and Week 48

,,,,
Interventionmm^3 (Mean)
Week 24Week 48
Ofatumumab 3 mg q12w43.154.2
Ofatumumab 30 mg q12w67.463.2
Ofatumumab 60 mg q12w65.0116.3
Ofatumumab 60mg q4w42.953.2
Placebo/Ofatumumab 3 mg86.9113.6

Trials

5 trials available for acetaminophen and Multiple Sclerosis, Relapsing-Remitting

ArticleYear
Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study.
    Neurology, 2018, 05-15, Volume: 90, Issue:20

    Topics: Acetaminophen; Administration, Oral; Adult; Analgesics, Non-Narcotic; Antibodies, Monoclonal; Antibo

2018
Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study.
    Neurology, 2018, 05-15, Volume: 90, Issue:20

    Topics: Acetaminophen; Administration, Oral; Adult; Analgesics, Non-Narcotic; Antibodies, Monoclonal; Antibo

2018
Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study.
    Neurology, 2018, 05-15, Volume: 90, Issue:20

    Topics: Acetaminophen; Administration, Oral; Adult; Analgesics, Non-Narcotic; Antibodies, Monoclonal; Antibo

2018
Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study.
    Neurology, 2018, 05-15, Volume: 90, Issue:20

    Topics: Acetaminophen; Administration, Oral; Adult; Analgesics, Non-Narcotic; Antibodies, Monoclonal; Antibo

2018
Corticosteroids, ibuprofen, and acetaminophen for IFNbeta-1a flu symptoms in MS: a randomized trial.
    Neurology, 2004, Aug-10, Volume: 63, Issue:3

    Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Asthenia; Chills; Double-Blind Method; Drug Administ

2004
A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis.
    Multiple sclerosis (Houndmills, Basingstoke, England), 2004, Volume: 10, Issue:6

    Topics: Acetaminophen; Adjuvants, Immunologic; Adult; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, No

2004
Alleviating flu-like symptoms with dose titration and analgesics in MS patients on intramuscular interferon beta-1a therapy: a pilot study.
    Current medical research and opinion, 2007, Volume: 23, Issue:7

    Topics: Acetaminophen; Adjuvants, Immunologic; Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Drug Thera

2007
Both paracetamol and ibuprofen are equally effective in managing flu-like symptoms in relapsing-remitting multiple sclerosis patients during interferon beta-1a (AVONEX) therapy.
    Multiple sclerosis (Houndmills, Basingstoke, England), 2002, Volume: 8, Issue:1

    Topics: Acetaminophen; Adult; Chills; Female; Fever; Headache; Humans; Ibuprofen; Interferon beta-1a; Interf

2002
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