A Study on the Effectiveness and Safety of Diazepam Injection (Vanquix™) for Patients With Epilepsy That Receive Antiepileptic Drugs, But Still Experience Acute Repetitive Seizures (Bouts or Clusters of Seizures) That Require Treatment - NCT00319501-20817(Clinical Trial 100146)
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20817 |
| Conditions: |
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Epilepsy - Epilepsy, Generalized - Epilepsy, Complex Partial - Epilepsies, Partial - Seizures |
| Purpose: |
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The purpose of this study is to determine if there is a difference in the number of seizures
and adverse events after a diazepam or placebo injection is given to control acute
repetitive seizures.
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| Study summary: |
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In the United States, more than 2 million people have epilepsy. Most patients with epilepsy
are able to control their seizures with drugs and/or surgery. However, many patients
(400,000 to greater than 600,000) are considered refractory to antiepileptic drugs and still
experience acute repetitive seizures (ARS). An ARS is an episode of multiple seizures that
differs from the patient's usual seizure pattern and is often recognizable by the patient's
family and caregivers. The ARS is usually described as a bout or cluster of seizures that
occurs over a short period of time in which the patient regains consciousness in between
seizures. Only one drug is currently available that persons other than health care
professionals (e.g., patient's caregiver) may give to control ARS. This drug is called
Diastat®. Diastat® is a diazepam rectal gel and, although it is effective, it may be
difficult, inconvenient, or objectionable to use because of its rectal administration.
Vanquix™ (diazepam autoinjector) also contains diazepam, but is administered by an automated
injectable device into the leg muscle. Vanquix™ may be less difficult and more convenient
to use by caregivers, however, its effectiveness and safety have not been studied in
patients. This study will determine the effectiveness and safety of Vanquix™ compared to
placebo for treating ARS. |
| Criteria: |
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Inclusion Criteria:
Inclusion Criteria for Patient:
- Clinical diagnosis of epilepsy, on a stable antiepileptic drug (AED) regimen for at
least 2 weeks, and requires 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 and not lactating and is practicing an acceptable method of birth
control
Inclusion Criteria for Caregiver(s):
- Is 18 years of age or older and is responsible
- Is available to accompany the patient to clinic visits
Exclusion Criteria:
- Petit mal status or petit mal variant status
- History of ARS consistently progressing to status epilepticus
- Has history of failure to respond to benzodiazepine treatment
- Hypersensitive to diazepam
- Acute narrow angle glaucoma
- Abuses alcohol and/or other substances
- Took another investigational drug in previous 30 days
- Acute or progressive neurological disease, severe psychiatric disease, or severe
mental abnormality |
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| Study is available at: |
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Mid-Atlantic Epilepsy and Sleep Center
Bethesda, MD 20817
United States
Primary Contact:
Tim Warneke
Phone: 919-653-7006 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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