Observational studyEpilepsia2020
Safety and tolerability associated with chronic intermittent use of diazepam buccal film in adult, adolescent, and pediatric patients with epilepsy.
Observational study in Epilepsia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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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.
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Who cites it
12 citing papers in PubMed, 13 citations in OpenAlex.
- Pharmacokinetics and 180-day safety of diazepam nasal spray in pediatric patients with epilepsy aged 2-5 years.Epilepsia · 2025Trial
- Buccal Insulin Delivery Systems: Formulation Approaches, Stability Constraints, and Translational Prospects.Pharmaceutics · 2026Review
- Benzodiazepines for the Treatment of Seizure Clusters.CNS drugs · 2024Review
- Immediate Treatment of Seizure Clusters: A Conceptual Roadmap to Expedited Seizure Management.Neuropsychiatric disease and treatment · 2024Review
- Treatment of Seizure Clusters in Epilepsy: A Narrative Review on Rescue Therapies.Neurology and therapy · 2023Review
- Overview about Oral Films in Mental Disorders.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Seizure Rescue Therapies: Comparing Approved and Commonly Used Benzodiazepine Formulations.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023Review
- Review
- Managing Acute Seizures: New Rescue Delivery Option and Resources to Assist School Nurses.NASN school nurse (Print) · 2021Article
- Overcoming the challenges of developing an intranasal diazepam rescue therapy for the treatment of seizure clusters.Epilepsia · 2021Article
- The unmet need for rapid epileptic seizure termination (REST).Epilepsy & behavior reports · 2021Review
- Observational
Corrections and comments
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Authors and funding
5 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveDiazepam buccal film (DBF) is in development for treatment of patients experiencing bouts of increased seizure activity. We assessed safety, tolerability, and usability of self- or caregiver-administered DBF in the outpatient setting.
methodsPatients aged 2-65 years needing treatment with a rescue benzodiazepine at least once monthly were eligible for the study. DBF (5-17.5 mg) was dispensed based on age and body weight. Patients/caregivers administered DBF for up to five seizure episodes per month. Adverse events (AEs) and usability assessments were recorded after the first dose, then every 3 months.
resultsOnehundred eighteen patients who used ≥1 DBF dose (adults, n = 82; adolescents, n = 19; children, n = 17) were enrolled. Eleven treatment-related AEs (10 being mild or moderate in severity) occurred in nine (7.6%) patients over a mean of 243 days of follow-up. No patient discontinued participation because of AEs. Mild local buccal discomfort, buccal swelling, and cheek skin sensitivity were reported by one patient each. Twenty-two serious AEs were reported; one was treatment-related. The three deaths reported, all unrelated to DBF, resulted from seizures or seizure with brain malignancy. Self-administration by adults was attempted on 23.6% (188/795) of use occasions. Administration of DBF occurred under ictal or peri-ictal conditions on 49.5% (538/1087) of use occasions, and DBF was successfully administered on a first or second attempt on 96.6% (1050/1087) of use occasions. Overall, patients received their dose of DBF on 99.2% (1078/1087) of use occasions. A second DBF dose was required within 24 hours after the first dose on 8.5% (92/1087) of use occasions. SIGNIFICANCE: In this observational study of chronic intermittent use, DBF was easy to administer, safe, and well tolerated in adult, adolescent, and pediatric patients with epilepsy experiencing seizure emergencies. DBF can be readily self-administered by adults with epilepsy, as well as successfully administered by a caregiver in seizure emergencies.
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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.