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

Condition(s) targeted: Epilepsy; Epilepsy, Generalized; Epilepsy, Complex Partial; Epilepsies, Partial; Seizures

Intervention: Diazepam (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: King Pharmaceuticals Research and Development

Official(s) and/or principal investigator(s):
Veeru Goli, M.D., Study Director, Affiliation: King Pharmaceuticals

Overall contact:
Tim Warneke, Phone: 919-653-7006

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to next seizure or rescue

Detailed description: 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.

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Tim Warneke, Phone: 919-653-7006

Neurology Clinic PC, Northport, Alabama 35476, United States; Recruiting
Alexandre Todorov, MD, Phone: 205-333-2626
Alexandre Todorov, MD, Principal Investigator

The University of Arizona, Tucson, Arizona 85724, United States; Withdrawn

Clinical Trials, Inc., Little Rock, Arkansas 72205, United States; Recruiting
Victor Biton, MD, Phone: 501-227-6179
Victor Biton, MD, Principal Investigator

Hoag Memorial Hospital Presbyterian, Newport Beach, California 92658, United States; Recruiting
Richard Kim, MD, Phone: 949-642-6787
Richard Kim, MD, Principal Investigator

Sacramento Comprehensive Epilepsy Center, Sacramento, California 95816, United States; Completed

Children's National Medical Center, Washington, District of Columbia 20010, United States; Withdrawn

Pediatric Neurology, PA, Orlando, Florida 32835, United States; Recruiting
Ronald Davis, MD, Phone: 407-293-1122
Ronald Davis, MD, Principal Investigator

Pediatric Epilepsy and Neurology Specialist, Tampa, Florida 33609, United States; Recruiting
Jose Ferreira, MD, Phone: 813-873-7367
Jose Ferreira, MD, Principal Investigator

Pediatric Neurology and Epilepsy Research Center, Loxahatchee, Florida 33470, United States; Recruiting
Edwin Liu, MD, Phone: 561-753-8888
Edwin Liu, MD, Principal Investigator

Bradenton Research Center, Bradenton, Florida 34205, United States; Recruiting
W. Alvin McElveen, MD, Phone: 941-708-0005
W. Alvin McElveen, MD, Principal Investigator

Winters Grant Tatum, Tampa, Florida 33613, United States; Completed

Morton Plant Mease Healthcare/Morton Plant Hospital Epilepsy Clinic, Clearwater, Florida 33756, United States; Recruiting
Daniel Cabello, MD, Principal Investigator

Emery Neuroscience Center, Fort Lauderdale, Florida 33308, United States; Completed

University of South Florida, Tampa, Florida 33606, United States; Withdrawn

Child Neurology Associates, PC, Atlanta, Georgia 30342, United States; Recruiting
Ray Cheng, MD, Phone: 404-256-3535
Raymond Cheng, MD, Principal Investigator

Savannah Neurology, PC, Savannah, Georgia 31405, United States; Recruiting
Eric Pearlman, MD, Phone: 912-790-4861
Eric Pearlman, MD, Principal Investigator

Medical College of Georgia, Augusta, Georgia 30912, United States; Withdrawn

Consultants in Epilepsy and Neurology, PLLC, Boise, Idaho 83702, United States; Recruiting
Robert Wechsler, MD, Phone: 208-381-7353
Robert Wechsler, MD, Principal Investigator

University of Chicago / Pediatric Epilepsy Center, Chicago, Illinois, United States; Recruiting
Michael Kohrman, MD, Principal Investigator

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States; Withdrawn

Kentucky Neuroscience Research, Louisville, Kentucky 40202, United States; Recruiting
Vinay Puri, MD, Principal Investigator

Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland 20817, United States; Withdrawn

Wayne State University, Detroit, Michigan, United States; Withdrawn

Neurology Clinic of St. Cloud, St. Cloud, Minnesota 56303, United States; Completed

Minnesota Epilepsy Group, PA, St Paul, Minnesota 55102, United States; Withdrawn

The Comprehensive Epilepsy Care Center For Children and Adults, Chesterfield, Missouri 63017, United States; Recruiting
William Rosenfeld, MD, Phone: 314-453-9300
William Rosenfeld, MD, Principal Investigator

St. Lukes Hospital, Kansas City, Missouri 64111, United States; Recruiting
John Croom, MD, Phone: 816-932-8277
John Croom, MD, Principal Investigator

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting
Gregory Holmes, MD, Phone: 603-650-7610
Gregory Holmes, MD, Principal Investigator

Clinical Research Center of New Jersey, Voorhees, New Jersey 08043, United States; Recruiting
Mark Mintz, MD, Phone: 856-346-1806
Mark Mintz, MD, Principal Investigator

Neurology Consultants of Burlington County, Lumberton, New Jersey 08048, United States; Withdrawn

University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey 08903, United States; Recruiting
Brenda Wu, MD, Phone: 732-235-7857
Brenda Wu, MD, Principal Investigator

Millard Fillmore Gates Circle Hospital, Buffalo, New York 14209, United States; Recruiting
Mona Sazgar, MD, Phone: 716-887-5404
Mona Sazgar, MD, Principal Investigator

University of Rochester, Rochester, New York 14642, United States; Recruiting
Albert Fessler, MD, Phone: 585-275-0404
Albert Fessler, MD, Principal Investigator

New York University Medical Center Comprehensive Epilepsy Center, New York, New York, United States; Recruiting
Blanca Vazquez, MD, Principal Investigator

Children's Hospital - Buffalo, Buffalo, New York, United States; Recruiting
Arie Weinstock, MD, Principal Investigator

Raleigh Neurology Associates, Raleigh, North Carolina 27607, United States; Recruiting
Traci Schaeffer, MD, Principal Investigator

Ohio State University Medical Center, Columbus, Ohio 43210, United States; Recruiting
Bassel Shneker, MD, Phone: 614-293-4974
Bassel Shneker, MD, Principal Investigator

Cleveland Clinic, Cleveland, Ohio 44195, United States; Completed

Riverside Methodist Hospital Epilepsy Center, Columbus, Ohio, United States; Withdrawn

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Lawrence Brown, MD, Phone: 215-590-1719
Lawrence Brown, MD, Principal Investigator

Wellspan Pediatric Neurology, York, Pennsylvania 17402, United States; Recruiting
Todd Barron, MD, Phone: 717-812-7025
Todd Barron, MD, Principal Investigator

Edisto Medical Services, Orangeburg, South Carolina 29118, United States; Recruiting
Mohammed Alhatou, MD, Phone: 803-531-8500
Mohammed Alhatou, MD, Principal Investigator

Medical University of South Carolina Comprehensive Epilepsy Program, Charleston, South Carolina, United States; Recruiting
Jonathan Halford, MD, Principal Investigator

Mid-South Physicians, Germantown, Tennessee 38138, United States; Completed

Pediatric Neurology Associates, Nashville, Tennessee 37203, United States; Completed

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Bassell Abou-Khalil, MD, Phone: 615-322-9557
Bassell Abou-Khalil, MD, Principal Investigator

UT Medical Group, Inc, Memphis, Tennessee 38105, United States; Recruiting
James Wheless, MD, Phone: 901-287-5207
James Wheless, MD, Principal Investigator

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Withdrawn

Alamo City Clinical Research, San Antonio, Texas 78258, United States; Completed

Neurological Clinic - Texas, Dallas, Texas 75230, United States; Recruiting
Robert Leroy, MD, Phone: 972-566-7690
Robert Leroy, MD, Principal Investigator

Dallas Pediatric Neurology Associates, Dallas, Texas 75230, United States; Withdrawn

Cook Children's Medical Center, Ft. Worth, Texas 76104, United States; Recruiting
Angel Hernandez, MD, Phone: 682-885-7860
Angel Hernandez, MD, Principal Investigator

Virginia Commonwealth University, Richmond, Virginia 23298, United States; Recruiting
Alan Towne, MD, Principal Investigator

University of Washington, Seattle, Washington 98104, United States; Recruiting
John Miller, MD, Phone: 206-731-3576
John Miller, MD, Principal Investigator

Starting date: January 2006
Ending date: August 2012
Last updated: September 8, 2009