Page last updated: 2024-10-31

modafinil and Adverse Drug Event

modafinil has been researched along with Adverse Drug Event in 9 studies

Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.
modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.
2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group.

Research Excerpts

ExcerptRelevanceReference
"Methylphenidate, modafinil, and amantadine are commonly prescribed medications for alleviating fatigue in multiple sclerosis; however, the evidence supporting their efficacy is sparse and conflicting."9.41Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial. ( Aljarallah, S; Auvray, C; Cordano, C; Creasman, J; Jin, C; Krysko, K; Manguinao, M; McCulloch, C; Morris, B; Mowry, E; Nourbakhsh, B; Revirajan, N; Rutatangwa, A; Waubant, E, 2021)
"This double-blind study evaluated the efficacy and safety of modafinil for treating excessive daytime sleepiness in Japanese patients with obstructive sleep apnea syndrome (OSAS)."9.17Efficacy and safety of adjunctive modafinil treatment on residual excessive daytime sleepiness among nasal continuous positive airway pressure-treated japanese patients with obstructive sleep apnea syndrome: a double-blind placebo-controlled study. ( Inoue, Y; Takasaki, Y; Yamashiro, Y, 2013)
"Methylphenidate, modafinil, and amantadine are commonly prescribed medications for alleviating fatigue in multiple sclerosis; however, the evidence supporting their efficacy is sparse and conflicting."5.41Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial. ( Aljarallah, S; Auvray, C; Cordano, C; Creasman, J; Jin, C; Krysko, K; Manguinao, M; McCulloch, C; Morris, B; Mowry, E; Nourbakhsh, B; Revirajan, N; Rutatangwa, A; Waubant, E, 2021)
"This double-blind study evaluated the efficacy and safety of modafinil for treating excessive daytime sleepiness in Japanese patients with obstructive sleep apnea syndrome (OSAS)."5.17Efficacy and safety of adjunctive modafinil treatment on residual excessive daytime sleepiness among nasal continuous positive airway pressure-treated japanese patients with obstructive sleep apnea syndrome: a double-blind placebo-controlled study. ( Inoue, Y; Takasaki, Y; Yamashiro, Y, 2013)
"The primary objective of this open-label pilot study was to evaluate the safety, and efficacy of modafinil in improving cancer-related fatigue (CRF) as measured by the Brief Fatigue Inventory (BFI)."5.14A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue. ( Baum, L; Blackhall, L; Farace, E; Petroni, G; Shu, J, 2009)
"Sodium oxybate (SXB) is an approved drug for the treatment of excessive daytime sleepiness (EDS) and cataplexy in narcolepsy."5.14A safety trial of sodium oxybate in patients with obstructive sleep apnea: Acute effects on sleep-disordered breathing. ( Feldman, N; George, CF; Grzeschik, SM; Inhaber, N; Lai, C; Steininger, TL; Zheng, Y, 2010)
"Modafinil was associated with DAAD in the total dataset (ROR, 2."1.46Sensitivity of Quantitative Signal Detection in Regards to Pharmacological Neuroenhancement. ( Connemann, BJ; Gahr, M; Schönfeldt-Lecuona, C; Zeiss, R, 2017)

Research

Studies (9)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (11.11)29.6817
2010's5 (55.56)24.3611
2020's3 (33.33)2.80

Authors

AuthorsStudies
Liu, Z1
Shi, Q1
Ding, D1
Kelly, R1
Fang, H1
Tong, W1
Sakatis, MZ1
Reese, MJ1
Harrell, AW1
Taylor, MA1
Baines, IA1
Chen, L1
Bloomer, JC1
Yang, EY1
Ellens, HM1
Ambroso, JL1
Lovatt, CA1
Ayrton, AD1
Clarke, SE1
Heller, MK1
Chapman, SCE1
Horne, R1
Elliott, J1
Johnston, A1
Husereau, D1
Kelly, SE1
Eagles, C1
Charach, A1
Hsieh, SC1
Bai, Z1
Hossain, A1
Skidmore, B1
Tsakonas, E1
Chojecki, D1
Mamdani, M1
Wells, GA1
Nourbakhsh, B1
Revirajan, N1
Morris, B1
Cordano, C1
Creasman, J1
Manguinao, M1
Krysko, K1
Rutatangwa, A1
Auvray, C1
Aljarallah, S1
Jin, C1
Mowry, E1
McCulloch, C1
Waubant, E1
Inoue, Y1
Takasaki, Y1
Yamashiro, Y1
Gahr, M1
Connemann, BJ1
Schönfeldt-Lecuona, C1
Zeiss, R1
Blackhall, L1
Petroni, G1
Shu, J1
Baum, L1
Farace, E1
George, CF1
Feldman, N1
Inhaber, N1
Steininger, TL1
Grzeschik, SM1
Lai, C1
Zheng, Y1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis[NCT03185065]Phase 3141 participants (Actual)Interventional2017-10-04Completed
A PILOT STUDY OF INTRAVENOUS, SUBANESTHETIC DOSE OF KETAMINE VS PLACEBO, A CROSSOVER DESIGN, FOR MULTIPLE SCLEROSIS RELATED FATIGUE[NCT06064162]Early Phase 120 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy[NCT01440621]Phase 3217 participants (Actual)Interventional2010-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Acceptability of Treatment as Assessed by a Single Question Questionnaire

"Participants will answer yes or no to this question: Taken into consideration the possible benefits and/or disadvantages of this medication, would you choose it, going forward to treat your MS fatigue?. The number of participants who answered Yes to this question is reported here." (NCT03185065)
Timeframe: Week 5 of each treatment period

InterventionParticipants (Count of Participants)
Placebo39
Amantadine41
Modafinil55
Methylphenidate55

Epworth Sleepiness Scale (ESS) Score

ESS score during the fifth week of treatment period. The ESS score can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo9.4
Amantadine9.3
Modafinil8.3
Methylphenidate8.8

Modified Fatigue Impact Scale (MFIS) Score

MFIS score during the fifth week of treatment period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo40.6
Amantadine41.3
Modafinil39.0
Methylphenidate38.6

Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score

Neuro-QoL Item Bank - Fatigue T score during the fifth week of treatment period. T-score distributions rescale raw scores into standardized scores with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores denote more severe fatigue. (NCT03185065)
Timeframe: Week 5 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Placebo53.1
Amantadine53.0
Modafinil52.5
Methylphenidate52.0

Reviews

1 review available for modafinil and Adverse Drug Event

ArticleYear
Pharmacologic treatment of attention deficit hyperactivity disorder in adults: A systematic review and network meta-analysis.
    PloS one, 2020, Volume: 15, Issue:10

    Topics: Adult; Amphetamine; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Bayes

2020

Trials

5 trials available for modafinil and Adverse Drug Event

ArticleYear
Beliefs About Medicines Predict Side-Effects of Placebo Modafinil.
    Annals of behavioral medicine : a publication of the Society of Behavioral Medicine, 2022, 10-03, Volume: 56, Issue:10

    Topics: Cognition; Drug-Related Side Effects and Adverse Reactions; Humans; Modafinil; Nocebo Effect; Pharma

2022
Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
    The Lancet. Neurology, 2021, Volume: 20, Issue:1

    Topics: Adult; Amantadine; Central Nervous System Stimulants; Cross-Over Studies; Double-Blind Method; Drug

2021
Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
    The Lancet. Neurology, 2021, Volume: 20, Issue:1

    Topics: Adult; Amantadine; Central Nervous System Stimulants; Cross-Over Studies; Double-Blind Method; Drug

2021
Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
    The Lancet. Neurology, 2021, Volume: 20, Issue:1

    Topics: Adult; Amantadine; Central Nervous System Stimulants; Cross-Over Studies; Double-Blind Method; Drug

2021
Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial.
    The Lancet. Neurology, 2021, Volume: 20, Issue:1

    Topics: Adult; Amantadine; Central Nervous System Stimulants; Cross-Over Studies; Double-Blind Method; Drug

2021
Efficacy and safety of adjunctive modafinil treatment on residual excessive daytime sleepiness among nasal continuous positive airway pressure-treated japanese patients with obstructive sleep apnea syndrome: a double-blind placebo-controlled study.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2013, Aug-15, Volume: 9, Issue:8

    Topics: Adult; Aged; Benzhydryl Compounds; Combined Modality Therapy; Continuous Positive Airway Pressure; D

2013
A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue.
    Journal of palliative medicine, 2009, Volume: 12, Issue:5

    Topics: Activities of Daily Living; Affect; Benzhydryl Compounds; Central Nervous System Stimulants; Drug-Re

2009
A safety trial of sodium oxybate in patients with obstructive sleep apnea: Acute effects on sleep-disordered breathing.
    Sleep medicine, 2010, Volume: 11, Issue:1

    Topics: Adjuvants, Anesthesia; Adult; Aged; Benzhydryl Compounds; Central Nervous System Stimulants; Comorbi

2010

Other Studies

3 other studies available for modafinil and Adverse Drug Event

ArticleYear
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
    PLoS computational biology, 2011, Volume: 7, Issue:12

    Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da

2011
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
    Chemical research in toxicology, 2012, Oct-15, Volume: 25, Issue:10

    Topics: Chemical and Drug Induced Liver Injury; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme

2012
Sensitivity of Quantitative Signal Detection in Regards to Pharmacological Neuroenhancement.
    International journal of molecular sciences, 2017, Jan-05, Volume: 18, Issue:1

    Topics: Adrenergic Uptake Inhibitors; Adverse Drug Reaction Reporting Systems; Atomoxetine Hydrochloride; Au

2017