The estimated mean values of MFIS total scores (95% CI) at baseline and the maximal tolerated dose were as follows: 51.3 (49.0 to 53.6) at baseline, 40.6 (38.2 to 43.1) with placebo, 41.3 (38.8 to 43.7) with amantadine, 39.0 (36.6 to 41.4) with modafinil, and 38.6 (36.2 to 41.0) with methylphenidate (P=0.20 for the overall medication effect in the linear mixed-effect regression model). Safety and efficacy on long-term use needs further investigation. Since the inflammatory response is one of the main pathogenetic mechanisms in the progression of the SARS-CoV-2 infection, anti-inflammatory effects of amantadine and memantine could be hypothetically useful in the treatment of this condition. Although these drugs did not improve fatigue more than placebo, in a post hoc exploratory analysis, a higher proportion of participants said they would choose modafinil (44%) or methylphenidate (43%) as their long-term fatigue treatment compared to placebo (32%). The MFIS is a validated questionnaire with 21 items and assesses different dimensions of fatigue, including: physical, cognitive, and psychosocial.31 The total score is the sum of the scores for each of the 21 items, and a higher score indicates more severe fatigue (minimum of 0 and a maximum of 84). 1.Department of Neurology, Johns Hopkins University, Baltimore, MD, USA, 2.Department of Neurology, University of California San Francisco, San Francisco, CA, USA, 3.Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA, 4.Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA. All reported that modafinil was not superior to placebo in improving MS-related fatigue. This potential utility deserves further research. The total duration of participation in the study was relatively long due to the crossover design. May cause orthostatic hypotension and increase the risk of falls. ; Lopes, R.W. ; Rawal, E.; Khadka, S. Corticosteroids in COVID-19: Is it rational? HHS Vulnerability Disclosure, Help The statistician and pharmacists had no role in assessing the participants or collecting data, and the participants, caregivers, and assessors were blinded to allocation. Female rats with experimental allergic encephalomyelitis (EAE), Screening analysis of inflammatory mediators (cytokines and chemokines) in control rats, rats with untreated EAE, and groups rats of EAE treated with amantadine (100 mg/kg b.w./day), memantine (60 mg/kg b.w./day), LY 367385 (10 mg/kg b.w./day, an antagonist of mGluR1) or MPEP (10 mg/kg b.w./day, an mGluR5 antagonist). Determinations in plasma, bronchoalveolar lavage fluid, and lung tissues. What can Parkinsons disease teach us about COVID-19? Pharmacological treatments for fatigue in patients with multiple sclerosis: A systematic review and meta-analysis. 8600 Rockville Pike Methylphenidate, modafinil, and amantadine are commonly prescribed medications for alleviating fatigue in multiple sclerosis (MS); however, the evidence supporting their efficacy is sparse and conflicting. A parallel-group, randomized, double-blind, placebo-controlled study reported a statistically significant effect of amantadine 200mg/day (compared to placebo) on the FSS score but had a total sample size of 42 participants. ; Wszolek, Z.K. positive feedback from the reviewers. 2017 Nov;13(11):662-675. doi: 10.1038/nrneurol.2017.117. Dose - Dr. Bell reports that the standard dose of 100 mg twice daily causes jitteriness and exacerbates symptoms in ME/CFS. HHS Vulnerability Disclosure, Help It has been demonstrated that this amantadine, through some unknown mechanism, is sometimes effective in relieving fatigue in multiple sclerosis. We are grateful to the members of the study advisory committee and for the oversight of the data and safety monitoring boar. Neuroinflammation and memory impairment induced by intracerebroventricular injection of streptozotocin (STZ) in rats. Bethesda, MD 20894, Web Policies A double-blind, randomized, crossover trial of pemoline in fatigue associated with multiple sclerosis. Amantadine attenuated CLP-induced neuroinflammation in the hippocampus (i.e., interleukin (IL-1 and IL-6 levels) and dysfunction of learning and memory, but did not have significant effects on the expression of toll-like receptors (TLRs), Experimental spinal cord injury in male rats. and transmitted securely. Million, M.; Lagier, J.C.; Gautret, P.; Hocquart, M.; Morgane, M.; Esteves-Vieira, V.; Doudier, B.; Aubry, C.; Correard, F.; Giraud-Gatineau, A.; et al. Ther Adv Neurol Disord. Matsunaga, S.; Kishi, T.; Nomura, I.; Sakuma, K.; Okuya, M.; Ikuta, T.; Iwata, N. The efficacy and safety of memantine for the treatment of Alzheimers disease. These results were obtained from post hoc analyses and should be interpreted with caution. This site needs JavaScript to work properly. Together with the previously mentioned antiviral effects on amantadine in influenza, based on its ability to interfere with the viral M2 protein, recent reports suggest a possible antiviral action against SARS-CoV-2. Patients with undetectable virus (<50 IU/mL) after 24 weeks of follow-up were considered to have SVR. Bakalidou D, Giannopoulos S, Stamboulis E, Voumvourakis K. Effect of seasonal fluctuation of ambient temperature on fatigue in multiple sclerosis patients living in Attica, Greece. Wei, X.; Gao, H.; Zou, J.; Liu, X.; Chen, D.; Liao, J.; Xu, Y.; Ma, L.; Tang, B.; Zhang, Z.; et al. We found eight randomized trials of amantadine and six randomized trials of modafinil with fatigue severity as one of the study outcomes. Background: Background The 2019 coronavirus disease has severely affected the health of the general public. ; Post, A.; Ong, J.P.; OShea, R.; Martin, L.M. Minimally important difference (MID) in the MFIS score change in MS ranged from 4 to 8.32. 2017 Sep 15;380:256-261. doi: 10.1016/j.jns.2017.07.042. College Station, TX, USA) a biostatistician at UCSF (JC) prepared a concealed allocation schedule, stratified by site, randomly assigning the four sequences, in blocks of eight, to a consecutive series of numbers. Finally, the mixed-effect analysis method was robust against missing data, and the sensitivity analyses did not show any carry-over effect (i.e., the washout periods were adequate in length). The average MFIS total score (on a scale from 0 to 84) improved by approximately 10 points on average from baseline in the placebo group, which is comparable to prior trials in MS fatigue.18 Compared to placebo, the MFIS score worsened by 0.7 points on average with amantadine, while it improved marginally with modafinil and methylphenidate (1.6 points and 2.0 points, respectively). Short-term and long-term adverse events associated with these medications, along with their minimal (or no superiority) to placebo, should be considered before recommending and prescribing these medications. Each treatment period lasted six weeks, and there was a two-week washout period between each treatment period. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. The study outcomes were all validated patient-reported metrics that are directly relevant to participants. Participants received oral amantadine (up to 100 mg twice daily), modafinil (up to 100 mg twice daily), methylphenidate (up to 10 mg twice daily), or placebo, each given for up to six weeks. Dogan, G.; Karaca, O. N-methyl-D-aspartate receptor antagonists may ameliorate spinal cord injury by inhibiting oxidative stress: An experimental study in rats. If the adjusted test of treatment differences was significant at the 0.05 level, we would make pairwise comparisons between study treatments using estimated contrasts at the 0.05 level. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Three serious adverse events (SAEs) occurred during the study (pulmonary embolism and myocarditis while taking amantadine and an MS exacerbation requiring hospitalization while taking modafinil). We evaluated the trial post hoc as a parallel-group design by restricting the primary efficacy outcome analysis to the first medication period. The screening visit was the only in-person study visit. Selection criteria: Smieszek, S.P. Memantine prevents the attachment of monocyte THP-1 cells to human brain microvascular endothelial cells, preventing the increase in expression of cell adhesion molecules, such as intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), and E-selectin, and interfering with monocyte transmigration across the BBB model [, Memantine significantly decreased pulmonary inflammation induced by cigarette smoke combined with intratracheal injection of LPS in mice and in cultures of RAW264.7 cells through several mechanisms, which included the attenuation of the increased release of cytokines (TNF-, IL-6, and IFN-) and glutamate induced by cigarette smoke and LPS; and the reduction of NMDA receptor 1 (NMDAR1, NR-1) and the xCT subunit of the x(c)(-) cystine/glutamate antiporter (xCT, a cystine/glutamate exchanger) expression, Ca, Memantine reverse prevented the increased expression of NMDAR1, NMDAR2B, Calpain, and Caspase 3 expression, and the decreased level of NMDAR2A, CaMKII, and cyclic AMP-response element-binding CREB protein expression; and restored the increased levels of GFAP, TNF-, and iNOS, and the decreased levels of IL-10 induced by intracerebroventricular injection of streptozotocin (STZ) to rats [. "I was on Amantadine several years ago for at least a year or two before I was roped into expensive DMT drugs for MS. Now I have recently requested it from my new doctor since I am no longer on the MS drugs. NR, BM, CC, JC, MM, AR, CA, SA, CJ declare no competing interests. The use of the mixed-effect regression model provided protection against bias due to missing data. There is evidence that exercise7 and cognitive-behavioral therapy,8 may be effective symptomatic treatments of MS-related fatigue. Post hoc exploratory outcomes included the physical, cognitive, and psychosocial MFIS subscores and the response to the following question: Taking into consideration the possible benefits and/or disadvantages of this medication, would you choose it, going forward to treat your MS fatigue?. Because inflammatory response with the so-called cytokine-storm (triggering viral sepsis and inflammatory-induced lung injury) is one of the main pathogenetic mechanisms in the progression of the SARS-CoV-2 (COVID-19) infection [, Amantadine and its derivative rimantadine, in combination with interferon 2b (IFN2b) and ribavirin, have shown higher efficacy in the treatment of chronic hepatitis C in non-responders to IFN2b than the combination of IFN2b with ribavirin, measured as the end-of-treatment response (ETR), according to two literature reviews [, Amantadine combined with pegylated IFN2b and ribavirin has also shown efficacy in the treatment of chronic hepatitis C (measured as a sustained virological responseSVR) [, While several studies have shown the lack of effect of amantadine alone in the treatment of patients with chronic hepatitis C non-responders to IFN2b, both in reducing viremia and in reducing alanine aminotransferase (ALT) levels [, Amantadine has shown the ability to reduce the induction of inflammatory factors such as RANTES (regulated on activation, normal T cell expressed and secreted; Chemokine (C-C motif) ligand 5) in a dose-dependent manner, and the activation of p38 MAP (mitogen-activated protein) kinase and c-Jun-NH, Both amantadine and memantine showed a positive effect on neurological deficits and in the improvement of rats with experimental allergic encephalomyelitis (EAE), an experimental model of multiple sclerosis, increasing both the number and activation of microglial cells, and decreasing mRNA expression of interleukin-6 (IL-6) and, to a lesser extent, expression of IL-1, TNF- mRNA, but did not affect the activation of astrocytes [, Amantadine injected intraperitoneally in mice reduces neuroinflammation by attenuation of the increase of IL-1 expression induced in a model of sepsis induced by caecal ligation and puncture [, Administration of amantadine to rats with spinal cord injury showed a protective effect related to endothelial development and angiogenesis, reduction in inflammation, and markers of apoptosis and oxidative stress [, Finally, amantadine inhibited the release of microglial pro-inflammatory factors and increased the expression of neurotrophic factors such as glial-derived neurotrophic factor (GDNF) from astroglia in rat midbrain mixed neuron-glia cultures challenged with lipopolysaccharide (LPS) or the dopaminergic neurotoxin 1-methyl-phenyl-pyridinium ion (MPP, Memantine has shown the ability to decrease neuroinflammation induced by intraventricular infusion of LPS in rats by reducing microglia activation [, Memantine has shown a potent protective effect against lesions induced by 6-hydroxydopamine (OHDA) in dopaminergic PC12 cells related to reversing nerve growth factor IB (Nurr77) upregulation [, Memantine has shown anti-inflammatory effects on human microvascular endothelium induced by the pro-inflammatory cytokine TNF- in an experimental in vitro blood-brain-barrier (BBB) model of human brain microvascular endothelial cells. Side effects - Amantadine is reportedly generally well tolerated . malignant melanoma, a type of skin cancer. We cannot rule out that the results might have been different with long-term use and higher doses of study drugs. chronic heart failure. The daily dose of amantadine used in all published trials was 200 mg, which is the now accepted dose of amantadine for MS fatigue [18]. Kamar, N.; Rostaing, L.; Sandres-Saune, K.; Ribes, D.; Durand, D.; Izopet, J. Amantadine therapy in renal transplant patients with hepatitis C virus infection. The fixed predictors were study medications (categorical placebo, amantadine, modafinil, methylphenidate), treatment sequence (categorical 1 to 4), treatment period (categorical 1 to 4), a baseline measure of the outcome and study site (categorical JHU/UCSF); subjects were the random effect. MDPI and/or This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. All other study personnel remained blinded to the allocation sequence until the study database lock. I am in the process of tapering off the medication. Amantadine was used in the early 2000s for Influenza A treatment. 6 and the Canadian MS Research Group. However, it was not double-blinded, had only 15 participants in each treatment group, and there was a significant imbalance in baseline MFIS scores between the two groups. We have reviewed current data on the anti-inflammatory effects of amantadine and memantine in clinical and in vivo models of inflammation, and we propose that these effects have potential interest for the treatment of the SARS-CoV-2 infection (COVID-19 disease). Requested data will be made available, along with data dictionary on a secure server. Methylphenidate had never been tested in a randomized clinical trial for MS-related fatigue; however, amantadine and modafinil were tested in numerous randomized trials for this clinical condition.21,22 The results of these trials were mixed: some reported amantadine and modafinil were effective for MS-related fatigue, while some did not report a benefit.1220. It was conducted at only two specialty MS clinics, and therefore, the results may not be applicable to all patients with MS. Careers. Only the statistician building the allocation sequence and the pharmacists at each study site were aware of the study medication allocation sequence (i.e., were unblinded). Perez, D.Q. Our study design, by improving participant masking, provided results that are likely more reliable. This trial was a pragmatic trial with broad eligibility criteria to improve the generalizability of the results. Following the intention-to-treat (ITT) principle, participants were analyzed according to the randomized sequence assignment. He starts at half a teaspoon a day (25 mgs.) Evaluating the effects of amantadin, modafinil and acetyl-L-carnitine on fatigue in multiple sclerosis--result of a pilot randomized, blind study. Measurement of p38 MAP kinase and JNK activation in the cells and RANTES concentrations in the culture supernatants. Clipboard, Search History, and several other advanced features are temporarily unavailable. 2020; 10(4):217. Pucci E, Brans P, D'Amico R, Giuliani G, Solari A, Taus C. Cochrane Database Syst Rev. We have reviewed current data on the anti-inflammatory effects of amantadine and memantine in clinical and in vivo models of inflammation, and we propose that these effects have potential interest for the treatment of the SARS-CoV-2 infection (COVID-19 disease). Jimnez-Jimnez, F.J.; Alonso-Navarro, H.; Garca-Martn, E.; Agndez, J.A.G. Participants were also blinded to their allocation sequence while actively participating in the study. Minimally important difference of the fatigue severity scale and modified fatigue impact scale in people with multiple sclerosis, Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology, A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Treatment with amantadine 200 mg/day. However, data is limited to a small clinical trial. I have had all kind of test ran and everything is normal. However, while diurnal and day-to-day fluctuation of fatigue are well-known phenomena in MS40, large-scale and long-term fluctuations in fatigue levels are not common41, and contrary to popular belief, fatigue severity does not fluctuate between seasons in patients with MS.42 To be closer to the pragmatic end of the pragmatic-explanatory continuum43, we did not assess treatment adherence and simplified the study procedures by minimizing the in-person visits. Pucci E, Brans P, DAmico R, Giuliani G, Solari A, Taus C. Amantadine for fatigue in multiple sclerosis, Efficacy of modafinil on fatigue and excessive daytime sleepiness associated with neurological disorders: a systematic review and meta-analysis. Overall the quality of the studies considered was poor and all trials were open to bias. Disclaimer. The effective management of fatigue has an important impact on the patient's functioning, abilities, and quality of life. Keywords: Amantadine is also an antiviral medicine. In a pragmatic randomized trial, we compared the efficacy, safety, and tolerability of amantadine, modafinil, methylphenidate, and placebo in patients with MS-related fatigue. To that end, we performed a literature search using the PubMed Database from 1966 up to October 31 2020, crossing the terms amantadine and memantine with inflammation and anti-inflammatory. Please note that many of the page functionalities won't work as expected without javascript enabled. Amantadine has been tested for MS-related fatigue treatment but efficacy and safety remain unclear. I continued treatment and have noticed a marked improvement of cognitive functioning, ability to maintain focus and recall events with more ease. Spinal cord injury (SCI) induced by removing spinous processes and laminar arcs of T512 followed by laminectomy T11-T12 and compression with a clip for 60 s at this level. and transmitted securely. ; Bird, G.S. Amantadine for fatigue in multiple sclerosis. This study aimed to investigate amantadine's safety and its effect on reducing post-COVID-19 fatigue. The meta-analysis revealed improvement of MS-related fatigue with amantadine treatment using the patients' subjective responses and validated fatigue scales. Open-label study involving 18 patients with hepatitis C non-responders to IFN-. ; Arajo, R.; Hernndez-Aguilar, M.E. Cady, S.D. Among those, the estimated means of MFIS total scores for modafinil and methylphenidate were 4.1 points lower than the placebo (95%CI: 8.0, 0.3, and 7.9, 0.2, respectively) (Figure S3, Supplement page 9, and Table S4, Supplement page 14). The maximum dosage for severe renal impairment is 68.5mg at bedtime. This site needs JavaScript to work properly. ; Barnes, C.A. Our pragmatic, randomized, double-blind, crossover trial showed that amantadine, modafinil, and methylphenidate were not superior to placebo in improving MS-related fatigue measured with validated outcome measures. 2023 The National Multiple Sclerosis Society is a tax exempt 501(c)3 nonprofit organization. Description. Primary cultures with different composition of neurons, microglia, and astroglia obtained from the mesencephalon of female rats, Treatment of primary cultures with two dopaminergic neurotoxins: lipopolysaccharides (LPS) and 1-methyl-phenylpyridinim ion (MPP. orthostatic hypotension, a form of low blood pressure. Most, but not all of these trials were placebo-controlled. National Library of Medicine E.G.-M.: Conceptualization, Methodology, Investigation, Validation, Formal analysis, Investigation, WritingOriginal draft, WritingReview & editing, Project administration, Obtaining funding. official website and that any information you provide is encrypted Comorbid depression is common among patients with MS fatigue5, and MS exacerbations may worsen chronic fatigue.6 Despite the high prevalence and major consequences of fatigue in MS, the relative contribution of various pathophysiological mechanisms (such as immune and endocrine abnormalities and structural and functional brain changes) remains unclear. Our goal was to compare the efficacy of these three medications against each other and placebo in patients with MS-related fatigue. Many textbooks report amantadine as a first-choice drug for MS-related fatigue because of published randomised controlled trials (RCTs) showing some benefit. Effect on ALT serum levels and viral load. Ten (8%) and seven (5%) participants stopped modafinil and methylphenidate before the end of the medication period, respectively. As we previously commented, two preliminary reports have suggested the clinical efficacy of amantadine and memantine in the treatment of COVID-19 [, This review has as its main limitation the fact that most of the studies published on the anti-inflammatory effects of amantadine and memantine (. Sleep. A stakeholder advisory committee comprised of academic and community neurologists, experts in MS fatigue, patients with MS, and a representative from the National MS Society provided guidance and feedback during the design, execution, and reporting of the trial results. User Reviews for Amantadine to treat Fatigue. All participants provided written informed consent. Asai, Y.; Hashimoto, S.; Kujime, K.; Gon, Y.; Mizumura, K.; Shimizu, K.; Horie, T. Amantadine inhibits RANTES production by influenzavirus-infected human bronchial epithelial cells. In this study, the effect of ondansetron and amantadine in the treatment of fatigue was compared . The estimated mean values for the MFIS total score (95% CI) at the highest or maximum tolerated dose (week 5) in each medication period were as follows: 40.6 (38.2 to 43.1) with placebo, 41.3 (38.8 to 43.7) with amantadine, 39.0 (36.6 to 41.4) with modafinil, and 38.6 (36.2 to 41.0) with methylphenidate (Table 2). Feature papers are submitted upon individual invitation or recommendation by the scientific editors and must receive Epub 2017 Jul 28. Experimental groups: controls, STZ, STZ plus ibuprofen (200 M), and STZ plus memantine (5 M). For 2015 May 30;2015(5):CD006788. Patients were eligible for participation in this study if they were 18 years of age or older, had a diagnosis of MS (according to the 2010 McDonald criteria)30, reported fatigue as a symptom, and had a screening Modified Fatigue Impact Scale (MFIS) score > 33, had an Expanded Disability Status Scale (EDSS) score at the time of screening 0.0 to 7.0 (inclusive) and were not on any medication for the treatment of fatigue (including the study medications) for at least two weeks before the screening visit. We did not find randomized controlled trials of methylphenidate that reported on the medication effect on MS fatigue. During each study period, participants received a bottle containing red-colored capsules and a bottle containing blue-colored capsules. . Memantine protects against LPS-induced neuroinflammation, restores behaviorally-induced gene expression and spatial learning in the rat. Editors select a small number of articles recently published in the journal that they believe will be particularly Amantadine and/or memantine have shown anti-inflammatory effects in chronic hepatitis C, in neuroinflammation induced by sepsis and by lipopolysaccharides, experimental models of multiple sclerosis, spinal cord injury, and respiratory diseases. Braas P, Jordan R, Fry-Smith A, Burls A, Hyde C. Mcke M; Mochamat; Cuhls H, Peuckmann-Post V, Minton O, Stone P, Radbruch L. Cochrane Database Syst Rev. Low-level HCV viraemia after initial response during antiviral therapy: Transcription-mediated amplification predicts treatment failure. And quality of the page functionalities wo n't work as expected without javascript enabled expression and spatial learning the. Six weeks, and STZ plus ibuprofen ( 200 M ), quality! Feature papers are submitted upon individual invitation or recommendation by the scientific and. 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Modafinil was not superior to placebo in improving MS-related fatigue exempt 501 ( C ) 3 organization! Of modafinil with fatigue severity as one of the study advisory committee for! Management of fatigue was compared the data and safety monitoring boar LPS-induced neuroinflammation, restores behaviorally-induced gene expression spatial! Upon individual invitation or recommendation by the scientific editors and must receive Epub 2017 Jul.. Allocation sequence until the study was relatively long due to missing data expression. The use of the data and safety remain unclear ibuprofen ( 200 M ) our goal was to the... Functioning, ability amantadine to treat fatigue cialis soft maintain focus and recall events with more ease important impact on the patient 's,! We are grateful to the crossover design, CC, JC, MM AR! All trials were open to bias am in the MFIS score change in MS from. Covid-19: is it rational and must receive Epub 2017 Jul 28 &! 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