Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2014
Armodafinil for the treatment of excessive sleepiness associated with mild or moderate closed traumatic brain injury: a 12-week, randomized, double-blind study followed by a 12-month open-label extension.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 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 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (50, 150, and 250 mg/Day) as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
A 12-Month, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil (150 and 250 mg/Day) as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Effectiveness of biomedical interventions on the chronic stage of traumatic brain injury: a systematic review of randomized controlled trials.Frontiers in neurology · 2024Pooled it
- Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021Pooled it
- Efficacy of oral modafinil on accelerating consciousness recovery in adult patients with moderate to severe acute traumatic brain injury admitted to intensive care unit: a randomized double-blind clinical trial.Neurosurgical review · 2024Trial
- Armodafinil as a Potential Pharmacological Treatment for Attention Deficit Hyperactivity Disorder in Adults: A Review.Current neuropharmacology · 2024Review
- Sleep, inflammation, and hemodynamics in rodent models of traumatic brain injury.Frontiers in neuroscience · 2024Review
- Traumatic brain injury and sleep in military and veteran populations: A literature review.NeuroRehabilitation · 2024Review
- Article
- Current and Potential Pharmacologic Therapies for Traumatic Brain Injury.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Idiopathic Hypersomnia and Other Hypersomnia Syndromes.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021Review
- Linking Traumatic Brain Injury, Sleep Disruption and Post-Traumatic Headache: a Potential Role for Glymphatic Pathway Dysfunction.Current pain and headache reports · 2019Review
- Neurotransmitter changes after traumatic brain injury: an update for new treatment strategies.Molecular psychiatry · 2019Review
- Hypocretin Mediates Sleep and Wake Disturbances in a Mouse Model of Traumatic Brain Injury.Journal of neurotrauma · 2019Article
- Sleep, Sleep Disorders, and Circadian Health following Mild Traumatic Brain Injury in Adults: Review and Research Agenda.Journal of neurotrauma · 2018Review
- Modafinil for the Improvement of Patient Outcomes Following Traumatic Brain Injury.Innovations in clinical neuroscience · 2018Review
- Traumatic Brain Injury, Sleep Disorders, and Psychiatric Disorders: An Underrecognized Relationship.Medical sciences (Basel, Switzerland) · 2018Review
- Sleep Disturbance After TBI.Current neurology and neuroscience reports · 2017Review
- Sleep-Wake Disturbances After Traumatic Brain Injury: Synthesis of Human and Animal Studies.Sleep · 2017Review
- Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated with Dementia with Lewy Bodies: A Pilot Study.Dementia and geriatric cognitive disorders · 2017Article
- Post-Concussive Syndrome: a Focus on Post-Traumatic Headache and Related Cognitive, Psychiatric, and Sleep Issues.Current neurology and neuroscience reports · 2016Review
- Sleep, Sleep Disorders, and Mild Traumatic Brain Injury. What We Know and What We Need to Know: Findings from a National Working Group.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2016Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and tolerability of armodafinil in patients with excessive sleepiness following mild or moderate closed traumatic brain injury (TBI).
designRandomized, placebo-controlled, double-blind trial followed by open-label extension.
setting40 US centers. PATIENTS: Adults with closed TBI (N = 117), Glasgow Coma Scale score >8 at time of injury; baseline Epworth Sleepiness Scale (ESS) ≥10; sleep latency <8 minutes on multiple sleep latency test (MSLT); and Clinical Global Impression-Severity of Illness (CGI-S) score ≥4 for excessive sleepiness.
interventionPatients received armodafinil (50, 150, or 250 mg/day) or placebo for 12 weeks followed by an optional 12-month open-label extension. MEASUREMENTS AND
resultsOutcomes included MSLT, ESS, Clinical Global Impression-Change (CGI-C), TBI-Work Instability Scale (TBI-WIS), CGI-S, and tolerability. The study was terminated early due to low enrollment. Patients receiving 250 mg armodafinil showed significant improvement in sleep latency from baseline to final visit versus placebo (+7.2 minutes vs. +2.4 minutes; p = 0.0010). CGI-C ratings were much/ very much improved in approximately 50% of patients receiving 150 and 250 mg armodafinil, compared to 38% on placebo. ESS and TBI-WIS scores were not significantly different between groups. In the open-label extension (N = 49), patients demonstrated gradual improvement in ESS, TBI-WIS, and CGI-S scores up to 48 weeks post-baseline. Armodafinil was generally well tolerated, with headache the most common adverse event in both double-blind and open-label portions.
conclusionsArmodafinil 250 mg significantly improved sleep latency in patients with excessive sleepiness associated with mild or moderate TBI. Efficacy and tolerability of armodafinil were sustained throughout the open-label extension.
trial registrationNCT00893789, NCT00983437.
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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.