Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters



Status:Terminated
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:12 - Any
Updated:4/17/2018
Start Date:June 2011

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

A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Intranasal Midazolam (USL261) in the Outpatient Treatment of Subjects With Seizure Clusters. ARTEMIS-1: Acute Rescue Therapy in Epilepsy With Midazolam Intranasal Spray-1

The purpose of this study is to examine the safety and effectiveness of USL261 for the
outpatient treatment of seizure clusters.


Inclusion Criteria:

- Has a competent, adult caregiver who can recognize and observe the subject's seizure
cluster episodes

- Has an established diagnosis of partial or generalized epilepsy that includes the
following:

- A documented history of seizure clusters lasting a minimum of 10 minutes

- Seizure cluster pattern is observable, stereotyped, and recognizably different
from the subject's other non-cluster seizure activity (if any)

- A second seizure in the seizure cluster typically occurring within 6 hours from
the time of cluster recognition

- A seizure cluster pattern composed of multiple (≥ 2) partial or generalized
seizures

- A seizure cluster pattern established > 3 months before Visit 1

- A frequency of ≥ 3 seizure clusters during the year before Visit 1

- At least 1 seizure cluster occurring ≤ 4 months before Visit 1

- Seizure cluster pattern is confirmed by a central reviewer

- Currently on a stable regimen of AEDs (no changes in type of AEDs) since Visit 1 and
for ≥ 7 days before Visit 2, with or without intermittent use of benzodiazepines at a
constant dose

- Weight is 40kg to 125kg, inclusive

Exclusion Criteria:

- Has a neurological disorder that is likely to progress in the next year

- Has severe chronic cardio-respiratory disease

- Has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1

- Has a history of their stereotypical seizure cluster progressing to status epilepticus
within the 2 years before Visit 1

- Has a history of acute narrow-angle glaucoma.

- Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before
Visit 1 or a suicide attempt in the past 5 years

- Currently using a VNS unless the device has been implanted for at least 6 months and
the setting stable for 4 weeks before Visit 1
We found this trial at
79
sites
Hackensack, New Jersey
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Akron, Ohio
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albany, New York
?
mi
from
Albany, NY
Click here to add this to my saved trials
Altamonte Springs, Florida
?
mi
from
Altamonte Springs, FL
Click here to add this to my saved trials
Aurora, Colorado
Phone: 866-372-0526
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland 21215
Phone: 866-372-0526
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bethesda, Maryland
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Boise, Idaho
Phone: 866-372-0526
?
mi
from
Boise, ID
Click here to add this to my saved trials
Bronx, New York
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Buffalo, New York
Phone: 866-372-0526
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Camden, New Jersey
Phone: 866-372-0526
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Charlottesville, Virginia
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chatswood, New South Wales 2067
?
mi
from
Chatswood,
Click here to add this to my saved trials
Chesterfield, Missouri
Phone: 866-372-0526
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Chicago, Illinois 60612
Phone: 866-372-0526
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Columbus, Ohio
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dallas, Texas
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75251
Phone: 866-372-0526
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75251
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dayton, Ohio
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
East Setauket, New York
?
mi
from
East Setauket, NY
Click here to add this to my saved trials
Flemington, New Jersey 08822
?
mi
from
Flemington, NJ
Click here to add this to my saved trials
Fort Worth, Texas
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fresno, California
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Gainesville, Florida
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Gibbsboro, New Jersey
?
mi
from
Gibbsboro, NJ
Click here to add this to my saved trials
Greenville, Texas
?
mi
from
Greenville, TX
Click here to add this to my saved trials
Gulf Breeze, Florida
Phone: 866-372-0526
?
mi
from
Gulf Breeze, FL
Click here to add this to my saved trials
Houston, Texas 77054
Phone: 866-372-0526
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana
Phone: 866-372-0526
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Irvine, California
Phone: 866-372-0526
?
mi
from
Irvine, CA
Click here to add this to my saved trials
Lebanon, New Hampshire
Phone: 866-372-0526
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Lexington, Kentucky
Phone: 866-372-0526
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Lexington, Kentucky
Phone: 866-372-0526
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Little Rock, Arkansas
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Loma Linda, California
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Loxahatchee Groves, Florida 33470
?
mi
from
Loxahatchee Groves, FL
Click here to add this to my saved trials
Madison, Wisconsin
?
mi
from
Madison, WI
Click here to add this to my saved trials
Manhattan, Kansas
?
mi
from
Manhattan, KS
Click here to add this to my saved trials
Marshfield, Wisconsin
?
mi
from
Marshfield, WI
Click here to add this to my saved trials
Memphis, Tennessee
Phone: 866-372-0526
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami, Florida
Phone: 866-372-0526
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida
?
mi
from
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee
Phone: 866-372-0526
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Brunswick, New Jersey
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
New Haven, Connecticut
Phone: 866-372-0526
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oxnard, California
?
mi
from
Oxnard, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania
Phone: 866-372-0526
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania
Phone: 866-372-0526
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona
Phone: 866-372-0526
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15224
Phone: 866-372-0526
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Port Charlotte, Florida
Phone: 866-372-0526
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
Portland, Oregon
?
mi
from
Portland, OR
Click here to add this to my saved trials
Reno, Nevada
Phone: 866-372-0526
?
mi
from
Reno, NV
Click here to add this to my saved trials
Richmond, Virginia
Phone: 866-372-0526
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Sacramento, California
Phone: 866-372-0526
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Sacramento, California
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Paul, Minnesota
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
Salt Lake City, Utah
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas
Phone: 866-372-0526
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78229
Phone: 866-372-0526
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85251
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Tampa, Florida
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Temple, Texas
?
mi
from
Temple, TX
Click here to add this to my saved trials
Tucson, Arizona
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Ventura, California
Phone: 866-372-0526
?
mi
from
Ventura, CA
Click here to add this to my saved trials
Virginia Beach, Virginia
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
Winston-Salem, North Carolina
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials