Efficacy and Safety of Vanquix for the Management of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Caregiver Medical Intervention to Control Episodes of Acute Repetitive Seizures.



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:2 - Any
Updated:12/28/2013
Start Date:January 2006
End Date:November 2014
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

Use our guide to learn which trials are right for you!

A Phase III, Randomized Double-Blind, Parallel, Placebo-Controlled, Multicenter Study, With Optional Open-Label Continuation, of the Safety and Efficacy of Vanquix Auto-Injector (Diazepam Injection) for the Management of Selected, Refractory Patients With Epilepsy Who Require Intermittent Medical Intervention to Control Episodes of Acute Repetitive Seizures

To evaluate the efficacy and safety of Vanquix for the management of selected, refractory,
patients with epilepsy who require intermittent medical intervention provided by caregivers
who are not health care professionals, and who are not under the direct supervision of a
healthcare professional at the time of administration to control episodes of acute
repetitive seizures (ARS).


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
We found this trial at
49
sites
New York, Pennsylvania 17403
2292
mi
from 91732
New York, PA
Click here to add this to my saved trials
Atlanta, Georgia 30309
1918
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
Boise, Idaho 83702
667
mi
from 91732
Boise, ID
Click here to add this to my saved trials
Bradenton, Florida 34205
2140
mi
from 91732
Bradenton, FL
Click here to add this to my saved trials
Buffalo, New York 14222
2181
mi
from 91732
Buffalo, NY
Click here to add this to my saved trials
Burlington, Massachusetts 01805
2570
mi
from 91732
Burlington, MA
Click here to add this to my saved trials
Charleston, South Carolina 29425
2183
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
Chesterfield, Missouri 63017
1552
mi
from 91732
Chesterfield, MO
Click here to add this to my saved trials
Chicago, Illinois 60611
1730
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Clearwater, Florida 33756
2117
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
Cleveland, Ohio 44195
2036
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
Columbus, Ohio 43210
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
Dallas, Texas 75204
1224
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
2315
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
1195
mi
from 91732
Fort Worth, TX
Click here to add this to my saved trials
Germantown, Tennessee 38138
1600
mi
from 91732
Germantown, TN
Click here to add this to my saved trials
Gibbsboro, New Jersey 08026
2386
mi
from 91732
Gibbsboro, NJ
Click here to add this to my saved trials
Greensboro, North Carolina 27405
2153
mi
from 91732
Greensboro, NC
Click here to add this to my saved trials
Gulf Breeze, Florida 32561
1814
mi
from 91732
Gulf Breeze, FL
Click here to add this to my saved trials
Irvine, California 92606
28
mi
from 91732
Irvine, CA
Click here to add this to my saved trials
Kansas City, Missouri 64111
1340
mi
from 91732
Kansas City, MO
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
2515
mi
from 91732
Lebanon, NH
Click here to add this to my saved trials
Lighthouse Point, Florida 33064
2314
mi
from 91732
Lighthouse Point, FL
Click here to add this to my saved trials
Little Rock, Arkansas 72205
1459
mi
from 91732
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90806
21
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
1812
mi
from 91732
Louisville, KY
Click here to add this to my saved trials
Memphis, Tennessee 38103
1585
mi
from 91732
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33155
2316
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37203
1762
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
2410
mi
from 91732
New Brunswick, NJ
Click here to add this to my saved trials
New York, New York 10029
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92663
31
mi
from 91732
Newport Beach, CA
Click here to add this to my saved trials
Northport, Alabama 35476
1744
mi
from 91732
Northport, AL
Click here to add this to my saved trials
Orangeburg, South Carolina 29118
2122
mi
from 91732
Orangeburg, SC
Click here to add this to my saved trials
Orlando, Florida 32819
2181
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19134
2378
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Portland, Oregon 97210
830
mi
from 91732
Portland, OR
Click here to add this to my saved trials
Raleigh, North Carolina 27607
2215
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
Richmond, Virginia 23298
2268
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
Rochester, New York 14642
2242
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
Sacramento, California 95816
365
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
San Antonio, Texas 78258
1184
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
Savannah, Georgia 31405
2126
mi
from 91732
Savannah, GA
Click here to add this to my saved trials
Seattle, Washington 98166
951
mi
from 91732
Seattle, WA
Click here to add this to my saved trials
St. Cloud, Minnesota 56303
1484
mi
from 91732
St. Cloud, MN
Click here to add this to my saved trials
Tallahassee, Florida 32308
1980
mi
from 91732
Tallahassee, FL
Click here to add this to my saved trials
Tampa, Florida 33609
2133
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Wellington, Florida 33414
2296
mi
from 91732
Wellington, FL
Click here to add this to my saved trials
York, Pennsylvania 17402
2296
mi
from 91732
York, PA
Click here to add this to my saved trials