Phase III Study of Intranasal Midazolam for Rescue Treatment of Seizure Clusters

Bernard

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MAPLE GROVE, Minn., July 18, 2011 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. announced today the initiation of a Phase III clinical trial to evaluate the safety and efficacy of USL261, an investigational intranasal midazolam, for the rescue treatment of seizures in patients on stable anti-epileptic drug (AED) regimens who require control of intermittent bouts of increased seizure activity, frequently referred to as seizure clusters. USL261 has been granted orphan drug designation for this use by the Food and Drug Administration (FDA).

The Phase III randomized, double-blind, placebo-controlled study, ARTEMIS1 ["Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray"], will compare intranasal midazolam, a benzodiazepine, with an intranasal placebo in males and females ages 14 to 65 years with a diagnosis of seizure clusters and who have a competent caregiver. The seizure clusters must have a pattern that is different from the individual's other non-cluster seizure activity and must be recognizable by a caregiver. USL261 may allow a caregiver to deliver an appropriate dose of the medication intranasally to an individual who is experiencing an intermittent bout of increased seizure activity. It is intended that this administration will not require an active inhalation by the patient.

The trial will enroll eligible patients with partial or generalized seizures who are on stable AED regimens. USL261 is the subject of a global Phase III clinical trial (ARTEMIS1), being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.

For more information on the study, please visit http://www.clinicaltrials.gov/ct2/show/NCT01390220?term=NCT01390220&rank=1.

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http://www.prnewswire.com/news-rele...-clusters-in-epilepsy-patients-125739248.html
 

Dutch mom

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Several Dutch kids I know do get nasal spray midazolam for several years now. Works well for some of them, for others it doesn't. When it doesn't, usually diastat, clonazapam and midazolam liquid didn't either. Those kids do get chloralhydrate and/or midazolam intramusculair or intravenair with a port-a-catch as rescue med in case of status epilepticus.
 

Endless

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This is huge for school children. There is a wide variety of policies regarding distat being administered in schools and day care centers. Having a nasal alternative might make at least a little difference, at least in the training and willingness by teachers to administer it. Though I guess not much of a difference when it comes to legalities.
 

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Upsher-Smith Laboratories, Inc. today announced the launch of http://www.seizureclusterstudy.com, an informational website for individuals diagnosed with partial or generalized epilepsy who experience seizure clusters and are interested in participating in an ongoing Phase III clinical trial. The study, ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray) is designed to evaluate the efficacy and safety of USL261, an investigational formulation of midazolam delivered intranasally, for the outpatient rescue treatment of seizure clusters. The website is the first of several planned initiatives to support the epilepsy community’s participation in this important clinical trial.

The new website, http://www.seizureclusterstudy.com provides individuals suffering from or diagnosed with epilepsy and their caregivers information about ARTEMIS1 including key eligibility requirements. In addition to the website, interested individuals can call 1-866-372-0526 to learn more or to locate study centers.
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Upsher-Smith announced yesterday that it is enrolling patients in its open-label safety extension study to ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray), a global Phase III clinical trial for USL261, a novel, investigational formulation of the benzodiazepine midazolam. The study will evaluate the long-term safety and tolerability of USL261 in the treatment of seizure clusters. USL261 has been granted orphan drug designation for this use by the FDA, and Upsher-Smith will be seeking approval for this indication.

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Potential study participants can visit www.clinicaltrials.gov (NCT# 01529034) to learn more about the eligibility criteria.

In addition to the open-label safety extension study, there is still an opportunity for interested patients to enroll in the ARTEMIS1 Trial. Potential participants can visit www.clinicaltrials.gov (NCT# 01390220) or www.seizureclusterstudy.com for more information.
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