Diazepam Clinical Trial

Open-label, Study of Safety and Tolerability of Chronic Intermittent Usage of Diazepam Nasal Spray in Epilepsy Patients With Cluster Seizures – Protocol DZNS-EP-1025.

ClinicalTrials.gov Identifier: NCT02316847

Inclusion Criteria:
•    Diagnosis of drug-resistant epilepsy
•    Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED)
•    Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit
•    A caregiver must consent to participate together with the subject for purposes of observation and data collection
•    The caregiver must be present when the investigational product is administered
•    Screening body weight between 26 to 111 kg, inclusive

Exclusion Criteria:
•    Female subject who is pregnant, breastfeeding, or planning to become pregnant
•    Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
•    Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components
•    Positive screening test for ethanol or other drugs of abuse
•    Unable to receive medications intranasally

Location:
David Vossler, MD and Carole Burton RN, Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057. Phone 1 425-251-1720

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Lacosamide Clinical Trial

A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy – Protocol SP0982.

ClinicalTrials.gov Identifier: NCT02408523

Inclusion Criteria:
•    Idiopathic generalized epilepsy (IGE) – primary generalized tonic-clonic seizures (PGTCS)
•    Age ≥4 years
•    ≥ 3 PGTCS during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
•    No imaging evidence of a lesion likely to be associated with partial-onset seizures
•    Stable dose regimen of 1 – 2 non-benzodiazepine marketed anti-epileptic drugs (AEDs) OR 1 – 3 AEDs (with at least 1 AED identified as a benzodiazepine) for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS)
•    An electroencephalogram (EEG) report consistent with IGE (eg, generalized ≥ 3Hz epileptiform discharges and a normal EEG background)
Exclusion Criteria:
•    History of partial onset seizures or EEG findings indicating partial onset seizures
•    Symptomatic generalized epilepsy, e.g. Lennox-Gastaut Syndrome
•    Lifetime history of suicide attempt, or suicidal ideation in past 6 months
•    Use of felbamate or vigabatrin within last 6 months
•    Subject is on a ketogenic diet

Location:
David Vossler, MD and Carole Burton RN, Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057. Phone 1 425-251-1720

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