Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.

NCT00319501

Last updated date
Study Location
Neurology Clinic, PC
Northport, Alabama, 35476, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Seizures, Partial Epilepsies, Complex Partial Epilepsy, Generalized Epilepsy, Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

For Patient:

- Older than 2 years of age and between 6 and 136 kg body weight

- Recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug regimen for at least 2 weeks, and requiring 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 or lactating and is practicing an acceptable method of birth control.

For Caregiver:

- Age of 18 years or older and has demonstrated responsibility as a caregiver through training to:

- Recognize an episode of repetitive seizures for which the injection was intended,

- Administer study drug

- Count and record seizures and respiratory rate in the patient diary,

- Monitor the patient and record observations in the patient diary for 12 hours following study drug treatment

- Recognize the need for immediate medical attention.

Key

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


For Patient:


- Petit mal status or petit mal variant status


- History of ARS consistently progressing to status epilepticus


- History of failure to respond to benzodiazepine treatment


- Hypersensitivity to diazepam


- Acute narrow angle glaucoma


- Alcohol and/or other substance abuse


- Has taken another investigational drug in previous 30 days


- Acute or progressive neurologic or severe psychiatric disease or severe mental
abnormality.

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Seizures, Partial Epilepsies, Complex Partial Epilepsy, Generalized Epilepsy, EpilepsyEfficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
NCT00319501
  1. Northport, Alabama
  2. Little Rock, Arkansas
  3. Irvine, California
  4. Long Beach, California
  5. Newport Beach, California
  6. Newport Beach, California
  7. Sacramento, California
  8. Sacramento, California
  9. Sacramento, California
  10. Sacramento, California
  11. Sacramento, California
  12. Bradenton, Florida
  13. Clearwater, Florida
  14. Clearwater, Florida
  15. Gulf Breeze, Florida
  16. Gulf Breeze, Florida
  17. Lighthouse Point, Florida
  18. Loxahatchee, Florida
  19. Miami, Florida
  20. Orlando, Florida
  21. Orlando, Florida
  22. Tallahassee, Florida
  23. Tallahassee, Florida
  24. Tampa, Florida
  25. Tampa, Florida
  26. Atlanta, Georgia
  27. Savannah, Georgia
  28. Boise, Idaho
  29. Chicago, Illinois
  30. Chicago, Illinois
  31. Chicago, Illinois
  32. Chicago, Illinois
  33. Louisville, Kentucky
  34. Louisville, Kentucky
  35. Louisville, Kentucky
  36. Burlington, Massachusetts
  37. St Cloud, Minnesota
  38. Chesterfield, Missouri
  39. Kansas City, Missouri
  40. Kansas City, Missouri
  41. Kansas City, Missouri
  42. Lebanon, New Hampshire
  43. Gibbsboro, New Jersey
  44. New Brunswick,, New Jersey
  45. New Brunswick, New Jersey
  46. Buffalo, New York
  47. Buffalo, New York
  48. Buffalo, New York
  49. New York, New York
  50. Rochester, New York
  51. Rochester, New York
  52. Greensboro, North Carolina
  53. Greensboro, North Carolina
  54. Raleigh, North Carolina
  55. Cleveland, Ohio
  56. Cleveland, Ohio
  57. Columbus, Ohio
  58. Columbus, Ohio
  59. Columbus, Ohio
  60. Portland, Oregon
  61. Philadelphia, Pennsylvania
  62. Philadelphia, Pennsylvania
  63. Philadelphia, Pennsylvania
  64. York, Pennsylvania
  65. York, Pennsylvania
  66. Charleston, South Carolina
  67. Charleston, South Carolina
  68. Charleston, South Carolina
  69. Orangeburg, South Carolina
  70. Germantown, Tennessee
  71. Memphis, Tennessee
  72. Nashville, Tennessee
  73. Nashville, Tennessee
  74. Nashville, Tennessee
  75. Nashville, Tennessee
  76. Nashville, Tennessee
  77. Dallas, Texas
  78. Fort Worth, Texas
  79. Fort Worth, Texas
  80. Ft Worth, Texas
  81. San Antonio, Texas
  82. Richmond, Virginia
  83. Richmond, Virginia
  84. Richmond, Virginia
  85. Seattle, Washington
  86. Seattle, Washington
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
Official Title  ICMJE A Phase 3, Randomized, Double-blind, Parallel, Placebo-controlled, Multicenter Study, With Optional Open-label Continuation, Of The Efficacy And Safety Of Vanquix(tm) 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
Brief Summary To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. In addition, to assess the support provided by caregivers who are not themselves or not under the direct supervision of health care professionals at the time of administration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Seizures
  • Epilepsies, Partial
  • Epilepsy, Complex Partial
  • Epilepsy, Generalized
  • Epilepsy
Intervention  ICMJE
  • Drug: Placebo
    Intramuscular autoinjector; administered at onset of an episode
  • Drug: Vanquix Auto-Injector (Diazepam Injection)
    Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
    Intervention: Drug: Placebo
  • Experimental: Diazepam
    During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, as a deep intramuscular injection in the mid to outer thigh. Additional doses were permissible during the Open-label Period. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
    Intervention: Drug: Vanquix Auto-Injector (Diazepam Injection)
Publications * Abou-Khalil B, Wheless J, Rogin J, Wolter KD, Pixton GC, Shukla RB, Sherman NA, Sommerville K, Goli V, Roland CL. A double-blind, randomized, placebo-controlled trial of a diazepam auto-injector administered by caregivers to patients with epilepsy who require intermittent intervention for acute repetitive seizures. Epilepsia. 2013 Nov;54(11):1968-76. doi: 10.1111/epi.12373. Epub 2013 Sep 20. Erratum in: Epilepsia. 2018 Dec;59(12):2344.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2012)
234
Original Enrollment  ICMJE
 (submitted: April 27, 2006)
325
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria

For Patient:

  • Older than 2 years of age and between 6 and 136 kg body weight
  • Recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug regimen for at least 2 weeks, and requiring 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 or lactating and is practicing an acceptable method of birth control.

For Caregiver:

  • Age of 18 years or older and has demonstrated responsibility as a caregiver through training to:

    • Recognize an episode of repetitive seizures for which the injection was intended,
    • Administer study drug
    • Count and record seizures and respiratory rate in the patient diary,
    • Monitor the patient and record observations in the patient diary for 12 hours following study drug treatment
    • Recognize the need for immediate medical attention.

Key Exclusion Criteria

For Patient:

  • Petit mal status or petit mal variant status
  • History of ARS consistently progressing to status epilepticus
  • History of failure to respond to benzodiazepine treatment
  • Hypersensitivity to diazepam
  • Acute narrow angle glaucoma
  • Alcohol and/or other substance abuse
  • Has taken another investigational drug in previous 30 days
  • Acute or progressive neurologic or severe psychiatric disease or severe mental abnormality.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00319501
Other Study ID Numbers  ICMJE K826-05-3001
B4511001 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP