Trial reportPloS one2013
Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting.
Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00884481 (A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months), which is not on this map. Cited by 54 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months
Who cites it
54 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- MS Fatigue Post High-Efficacy Treatment.European journal of neurology · 2025Pooled it
- Antidepressant activity of anti-cytokine treatment: a systematic review and meta-analysis of clinical trials of chronic inflammatory conditions.Molecular psychiatry · 2018Pooled it
- Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2020Trial
- Treatment satisfaction, adherence and behavioral assessment in patients de-escalating from natalizumab to interferon β.BMC neurology · 2014Trial
- Data-Driven Fatigue Trajectories in Multiple Sclerosis and Their Predictors.Neurology(R) neuroimmunology & neuroinflammation · 2026Article
- Fatigue: a common but poorly understood symptom in neurological and non-neurological diseases.Nature reviews. Neurology · 2025Review
- Impact of Natalizumab on Productivity and Ability to Work in Patients with Multiple Sclerosis in France: The TITAN Study.Neurology and therapy · 2025Article
- Article
- Trajectories of self-reported fatigue following initiation of multiple sclerosis disease-modifying therapy.Journal of neurology, neurosurgery, and psychiatry · 2024Observational
- Pediatric-onset Multiple Sclerosis treatment: a multicentre observational study comparing natalizumab with fingolimod.Journal of neurology · 2024Observational
- The Effectiveness of Vitamin D Intake in Improving Symptoms and Relapses of Multiple Sclerosis: A Systematic Review.Cureus · 2024Review
- Insight into motor fatigue mechanisms in natalizumab treated multiple sclerosis patients with wearing off.Scientific reports · 2024Article
- Effects of multidisciplinary inpatient rehabilitation on everyday life physical activity and gait in patients with multiple sclerosis.Journal of neuroengineering and rehabilitation · 2024Article
- Intravenous or subcutaneous natalizumab in patients with relapsing-remitting multiple sclerosis: investigation on efficiency and savings-the EASIER study.Journal of neurology · 2024Observational
- Real-world evidence and patient preference for subcutaneousTherapeutic advances in neurological disorders · 2024Article
- Brain FADE syndrome: the final common pathway of chronic inflammation in neurological disease.Frontiers in immunology · 2024Review
- Impact of Disease Modifying Therapy on MS-Related Fatigue: A Narrative Review.Brain sciences · 2023Review
- Assessment of Upper Extremity Function in Multiple Sclerosis: Feasibility of a Digital Pinching Test.JMIR formative research · 2023Article
- Sleep counts! Role and impact of sleep in the multimodal management of multiple sclerosis.Journal of neurology · 2023Review
- Management of multiple sclerosis fatigue in the digital age: from assessment to treatment.Frontiers in neuroscience · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledFatigue is a significant symptom in multiple sclerosis (MS) patients. First-generation disease modifying therapies (DMTs) are at best moderately effective to improve fatigue. Observations from small cohorts have indicated that natalizumab, an antibody targeting VLA-4, may reduce MS-related fatigue. The TYNERGY study aimed to further evaluate the effects of natalizumab treatment on MS-related fatigue. In this one-armed clinical trial including 195 MS patients, natalizumab was prescribed in a real-life setting, and a validated questionnaire, the Fatigue Scale for Motor and Cognitive functions (FSMC), was used both before and after 12 months of treatment to evaluate a possible change in the fatigue experienced by the patients. In the treated cohort all measured variables, that is, fatigue score, quality of life, sleepiness, depression, cognition, and disability progression were improved from baseline (all p values<0.0001). Walking speed as measured by the six-minute walk-test also increased at month 12 (p = 0.0016). All patients were aware of the nature of the treatment agent, and of the study outcomes.
conclusionNatalizumab, as used in a real-life setting, might improve MS-related fatigue based on the results from this one-armed un-controlled stud. Also other parameters related to patients' quality of life seemed to improve with natalizumab treatment.
trial registrationClinicalTrials.gov NCT00884481.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.