Trial reportCurrent medical research and opinion2014
An open-label multicenter study to assess the safety of dextromethorphan/quinidine in patients with pseudobulbar affect associated with a range of underlying neurological conditions.
Trial report in Current medical research and opinion, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00056524 (An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.), which is not on this map. Cited by 14 papers, 1 of them a synthesis 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.
An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.
- Pharmacotherapy for the Pseudobulbar Affect in Individuals Who Have Sustained a Traumatic Brain Injury: a Systematic Review.Neuropsychology review · 2020Pooled it
- Assessing the efficacy of dextromethorphan/quinidine in treating irritability in Huntington's disease.Journal of Huntington's disease · 2026Trial
- A Randomized, Placebo-Controlled, Blinded, Crossover, Pilot Study of the Effects of Dextromethorphan/Quinidine for the Treatment of Neurobehavioral Symptoms in Adults with Autism.Journal of autism and developmental disorders · 2020Trial
- Enhanced Bulbar Function in Amyotrophic Lateral Sclerosis: The Nuedexta Treatment Trial.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2017Trial
- PRISM II: an open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury.BMC neurology · 2016Trial
- Pseudobulbar Affect: A Network Disorder Linking Emotion, Neurobiology, and Therapeutics.Cureus · 2025Review
- Behavioral disorders in multiple sclerosis: a comprehensive review.Journal of neural transmission (Vienna, Austria : 1996) · 2025Review
- Progressive Supranuclear Palsy and Corticobasal Degeneration.Advances in experimental medicine and biology · 2021Article
- Progressive supranuclear palsy: Advances in diagnosis and management.Parkinsonism & related disorders · 2020Review
- Irritability in Huntington's Disease.Journal of Huntington's disease · 2020Review
- Pseudobulbar Affect in Parkinsonian Disorders: A Review.Journal of movement disorders · 2019Article
- Hypothalamic relapse of a cardiac large B-cell lymphoma presenting with memory loss, confabulation, alexia-agraphia, apathy, hypersomnia, appetite disturbances and diabetes insipidus.BMJ case reports · 2018Article
- Cutaneous Adverse Effects of Neurologic Medications.CNS drugs · 2016Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPseudobulbar affect (PBA) is associated with neurological disorders or injury affecting the brain, and characterized by frequent, uncontrollable episodes of crying and/or laughing that are exaggerated or unrelated to the patient's emotional state. Clinical trials establishing dextromethorphan and quinidine (DM/Q) as PBA treatment were conducted in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). This trial evaluated DM/Q safety in patients with PBA secondary to any neurological condition affecting the brain.
objectiveTo evaluate the safety and tolerability of DM/Q during long-term administration to patients with PBA associated with multiple neurological conditions.
methodsFifty-two-week open-label study of DM/Q 30/30 mg twice daily. Safety measures included adverse events (AEs), laboratory tests, electrocardiograms (ECGs), vital signs, and physical examinations. CLINICAL
trial registration#NCT00056524.
resultsA total of 553 PBA patients with >30 different neurological conditions enrolled; 296 (53.5%) completed. The most frequently reported treatment-related AEs (TRAEs) were nausea (11.8%), dizziness (10.5%), headache (9.9%), somnolence (7.2%), fatigue (7.1%), diarrhea (6.5%), and dry mouth (5.1%). TRAEs were mostly mild/moderate, generally transient, and consistent with previous controlled trials. Serious AEs (SAEs) were reported in 126 patients (22.8%), including 47 deaths, mostly due to ALS progression and respiratory failure. No SAEs were deemed related to DM/Q treatment by investigators. ECG results suggested no clinically meaningful effect of DM/Q on myocardial repolarization. Differences in AEs across neurological disease groups appeared consistent with the known morbidity of the primary neurological conditions. Study interpretation is limited by the small size of some disease groups, the lack of a specific efficacy measure and the use of a DM/Q dose higher than the eventually approved dose.
conclusionsDM/Q was generally well tolerated over this 52 week trial in patients with PBA associated with a wide range of neurological conditions.
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What OpenQuestion holds
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.