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Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.

Last updated on March 15, 2019

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Study Location
Neurology Clinic, PC
Northport, Alabama, 35476 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Seizures, Partial Epilepsies, Complex Partial Epilepsy, Generalized Epilepsy, Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00319501
Pfizer
Completed
Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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