Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
2–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For Patient:
Older than 2 years of age and between 6 and 136 kg body weight
Recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug regimen for at least 2 weeks, and requiring intermittent medical intervention to control episodes of acute repetitive seizures (ARS)
Experienced at least 2 episodes of ARS in previous year, one of which occurred in previous 6 months
Has episodes of ARS that include complex partial or generalized seizures
Has a responsible caregiver available to participate
Is not pregnant or lactating and is practicing an acceptable method of birth control.
For Caregiver:
Age of 18 years or older and has demonstrated responsibility as a caregiver through training to:
* Recognize an episode of repetitive seizures for which the injection was intended,
* Administer study drug
* Count and record seizures and respiratory rate in the patient diary,
* Monitor the patient and record observations in the patient diary for 12 hours following study drug treatment
* Recognize the need for immediate medical attention.
You may not be if
For Patient:
Petit mal status or petit mal variant status
History of ARS consistently progressing to status epilepticus
History of failure to respond to benzodiazepine treatment
Hypersensitivity to diazepam
Acute narrow angle glaucoma
Alcohol and/or other substance abuse
Has taken another investigational drug in previous 30 days
Acute or progressive neurologic or severe psychiatric disease or severe mental abnormality.
Clareo Health | Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
