Trial Information
Summary: Refractory Epilepsy and acute repetitive seizures (ARS)
We are conducting a clinical research study for volunteers
diagnosed with Refractory Epilepsy with acute repetitive seizures
(ARS) that require intermittent medical intervention. This study
tests the effectiveness and safety of an investigational drug for
the management of selected refractory patients with episodes of
ARS.
Study Criteria:
- Age = 2
- Diagnosis of Epilepsy
- Stable dose of AED for at least 2 weeks
- Patients receiving vagus nerve stimulation (VNS) are eligible
if they have been on VNS for at least six months and the settings
have been stable for 2 weeks
- Experienced at least 2 episodes of ARS in the last yea=r, one
of which must have occurred in the previous six months
- Sufficient muscle mass for an injection into the thigh
muscle
- has a responsive caregiver, 18 years of age and older that can
administer study drug and monitor patient seizures and respiratory
rate
- No pregnant or lactating women
- No history of consistent progression from episodes of ARS to
status epilepticus
- No history of failure to respond to benzodiazepine
treatment
- No hypersensitivity to diasepam
- No acute narrow angle glacoma
- No alcohol or substance abuse
- No investigational drug within 30 days
- No acute or progressive neurological disease, severe
psychiatric disease, or severe mental abnormality
- no significant cardio-respiratory, renal or hepatic
condition
If eligible, you will receive investigational drug and
study-related medical tests at no cost. Compensation for time and
travel may also be available.
For additional information about this study or to enroll, visit
our website:
www.clinicaltrialsinc.com
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Contact:
Lauren Landers
Clinical Trials, Inc.
Two Lile Court, Suite 100
Little Rock, AR 72205
Telephone: 501-227-8179
Fax: 501-221-3426
Email:
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Trial listings updated: June 1, 2008 at 6:33:30 AM