Evidence map›Paper›PMID 35975599›Full record

ArticleEpilepsia2022

Significant improvements in SEIzure interVAL (time between seizure clusters) across time in patients treated with diazepam nasal spray as intermittent rescue therapy for seizure clusters.

Sunita N Misra, Michael R Sperling, Vikram R Rao, Jurriaan M Peters, Charles Davis, Enrique Carrazana, Adrian L Rabinowicz

Open access · hybridAbstract read
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In one paragraph

Article in Epilepsia, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.8field-weighted citation impact, top 8% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 21 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 1 country.

Sunita N MisraNeurelis, Inc., San Diego, California, USA.ORCID 0000-0002-7624-8825
Michael R SperlingThomas Jefferson University, Philadelphia, Pennsylvania, USA.ORCID 0000-0003-0708-6006
Vikram R RaoUniversity of California, San Francisco, San Francisco, California, USA.ORCID 0000-0002-6389-2638
Jurriaan M PetersBoston Children's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-6725-2814
Charles DavisCSD Biostatistics, Oro Valley, Arizona, USA.
Enrique CarrazanaNeurelis, Inc., San Diego, California, USA.ORCID 0000-0001-8788-0722
Adrian L RabinowiczNeurelis, Inc., San Diego, California, USA.ORCID 0000-0003-1299-0606
Neurelis (United States) · USBoston Children's Hospital · USNimbis Services (United States) · USThomas Jefferson University · USUniversity of California, San Francisco · USUniversity of Hawaiʻi at Mānoa · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIntermittent rescue therapy may be used for seizure clusters, which are clinical emergencies that may persist ≥24 h and increase risk of status epilepticus, emergency room visits, and reduced quality of life for patients with epilepsy. Beyond effectiveness for aborting seizure clusters, no data exist on how intermittent rescue therapy may impact the long-term natural course of seizure clusters. This novel analysis explores SEIzure interVAL (SEIVAL; time between seizure clusters) in patients from a long-term safety study of diazepam nasal spray (Valtoco) to assess SEIVAL changes with intermittent rescue therapy across time.

methodsPatients were aged 6-65 years. Age- and weight-based doses of diazepam nasal spray were administered during a 12-month treatment period with an optional follow-up period. SEIVAL was evaluated in patients receiving two or more doses of diazepam nasal spray using 90-day periods.

resultsOf 163 treated patients, 151 had one or more SEIVALs. One hundred twenty had SEIVALs in Period 1 and one or more other periods. An increase in SEIVAL was noted from Period 1 compared with all subsequent periods (p ≤ .001). A consistent cohort (n = 76) had one or more SEIVALs in each of Periods 1-4 (360 days); mean SEIVALs increased significantly (p < .01) from 12.2 days (Period 1) to 25.7 days (Period 4). Similar SEIVAL patterns occurred when repeat doses within a seizure cluster were eliminated and irrespective of age group, treatment duration, and change to concomitant medications. In adults, Quality of Life in Epilepsy scores were maintained with increased SEIVALs. SIGNIFICANCE: Across 12 months, increases in SEIVAL were demonstrated in patients using diazepam nasal spray for seizure cluster treatment in a phase 3 safety study. Increased time between seizure clusters may reflect a previously unrecognized beneficial effect of intermittent rescue therapy. These results generate a range of biological and behavioral hypotheses and warrant exploration of the impact of intermittent rescue therapy.

Indexed as

EpilepsyEpilepsy, GeneralizedAdministration, IntranasalAdultAnticonvulsantsBrain Damage, ChronicDiazepamHumansNasal SpraysQuality of LifeSeizuresAnticonvulsantsDiazepamNasal Spraysacute repetitive seizuresbenzodiazepineintranasalrescue

Identifiers

PMID35975599
OpenAlexW4289917712

What OpenQuestion holds

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Registered trials

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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.