A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years

NCT01389596

Last updated date
Study Location
Center for Neurosciences
Tucson, Arizona, 85718, 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.
Partial Seizures Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4-16 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily seizure diaries and monitor seizure frequency.

- Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the Screening Visit.

- Diagnosis of epilepsy with partial onset seizures classified as simple partial, complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE) Diagnosis criteria.

- Must have a partial onset seizure frequency of at least 3 seizures per 28 day period prior to screening. Must have a partial onset seizure frequency of at least 6 seizures and no continuous 4 week seizure free period during the 8 week baseline phase prior to randomization.

- Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).

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


- Primary generalized seizures (including in the setting of co-existing partial onset
seizures) which include, for example: Clonic, tonic and clonic-tonic seizures (note
that partial onset seizures that become secondarily generalized are not exclusionary);
Absence seizures; Infantile spasms; Myoclonic, myoclonic atonic, myoclonic tonic
seizures.


- Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet
syndrome.


- A current diagnosis of febrile seizures, or seizures related to an ongoing acute
medical illness. Any febrile seizures within 1 year of screening.


- Status epilepticus within 1 year prior to screening.


- Seizures related to drugs, alcohol, or acute medical illness.


- Any change in AED regimen (type of medication or dose) within 28 days of the Screening
Visit or during the Baseline Phase.


- Progressive structural CNS lesion or a progressive encephalopathy.

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Partial Seizures EpilepsyA Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years NCT01389596
  1. Tucson, Arizona
  2. Little Rock, Arkansas
  3. Los Angeles, California
  4. Los Angeles, California
  5. Loxahatchee Groves, Florida
  6. North Palm Beach, Florida
  7. Orlando, Florida
  8. Tallahassee, Florida
  9. Lexington, Kentucky
  10. Lexington, Kentucky
  11. Lexington, Kentucky
  12. Lexington, Kentucky
  13. Louisville, Kentucky
  14. Louisville, Kentucky
  15. Louisville, Kentucky
  16. New Brunswick, New Jersey
  17. Durham, North Carolina
  18. Durham, North Carolina
  19. Akron, Ohio
  20. San Antonio, Texas
  21. Ottignies, Brabant Wallon
  22. Brussels, Brussels-capital
  23. Brussels,
  24. Plovdiv,
  25. Brno - Cerna Pole,
  26. Praha 5,
  27. Bordeaux,
  28. Bron,
  29. Garches,
  30. Strasbourg,
  31. Athens,
  32. Athens,
  33. Balassagyarmat,
  34. Budapest,
  35. Budapest,
  36. Budapest,
  37. Budapest,
  38. Pécs,
  39. Haifa,
  40. Ancona,
  41. Firenze,
  42. Pavia,
  43. Pavia,
  44. Seoul,
  45. Seoul,
  46. Seoul,
  47. Ipoh, Perak
  48. Kuala Lumpur,
  49. Cebu City, Cebu
  50. Sta. Cruz, Manila
  51. Quezon City, National Capital Region
  52. Cebu City,
  53. Manila,
  54. Quezon City,
  55. Quezon City,
  56. Gdansk,
  57. Kielce,
  58. Krakow,
  59. Poznan,
  60. Wroclaw,
  61. Bucuresti,
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  64. Sibiu,
  65. Timisoara,
  66. Novi Sad, Vojvodina
  67. Belgrade,
  68. Belgrade,
  69. Kragujevac,
  70. Singapore,
  71. Singapore,
  72. Izmir, Bornova
  73. Trabzon, Farabi
  74. Izmir, Konak
  75. Izmir, Konak
  76. Istanbul, Pendik
  77. Ankara, Sihhiye/ankara
  78. Dnipropetrovsk,
  79. Dnipropetrovsk,
  80. Kharkiv,
  81. Kharkiv,
  82. Kyiv,
  83. Odesa,
  84. Odesa,
  85. S. Oleksandrivka,
  86. Uzhgorod,
ALL GENDERS
4 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
Official Title  ICMJE A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES
Brief Summary Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy, Partial Seizures
Intervention  ICMJE Drug: Pregabalin add-on therapy
Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Pregabalin add-on therapy
  • Experimental: Pregabalin Level 1 (max 150 mg/day)
    Intervention: Drug: Pregabalin add-on therapy
  • Experimental: Pregabalin Level 2 (max 600 mg day)
    Intervention: Drug: Pregabalin add-on therapy
Publications * Antinew J, Pitrosky B, Knapp L, Almas M, Pitman V, Liu J, Craiu D, Modequillo M, Nordli D, Farkas V, Farkas MK. Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial. J Child Neurol. 2019 Apr;34(5):248-255. doi: 10.1177/0883073818821035. Epub 2019 Jan 27.

*   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: March 23, 2017)
295
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2011)
153
Actual Study Completion Date  ICMJE August 10, 2016
Actual Primary Completion Date August 10, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily seizure diaries and monitor seizure frequency.
  • Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the Screening Visit.
  • Diagnosis of epilepsy with partial onset seizures classified as simple partial, complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE) Diagnosis criteria.
  • Must have a partial onset seizure frequency of at least 3 seizures per 28 day period prior to screening. Must have a partial onset seizure frequency of at least 6 seizures and no continuous 4 week seizure free period during the 8 week baseline phase prior to randomization.
  • Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).

Exclusion Criteria:

  • Primary generalized seizures (including in the setting of co-existing partial onset seizures) which include, for example: Clonic, tonic and clonic-tonic seizures (note that partial onset seizures that become secondarily generalized are not exclusionary); Absence seizures; Infantile spasms; Myoclonic, myoclonic atonic, myoclonic tonic seizures.
  • Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome.
  • A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness. Any febrile seizures within 1 year of screening.
  • Status epilepticus within 1 year prior to screening.
  • Seizures related to drugs, alcohol, or acute medical illness.
  • Any change in AED regimen (type of medication or dose) within 28 days of the Screening Visit or during the Baseline Phase.
  • Progressive structural CNS lesion or a progressive encephalopathy.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 4 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Czechia,   France,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Philippines,   Poland,   Romania,   Serbia,   Singapore,   Turkey,   Ukraine,   United States
Removed Location Countries Austria,   Czech Republic,   Estonia,   Finland,   India,   Lithuania,   Netherlands,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT01389596
Other Study ID Numbers  ICMJE A0081041
2010-020852-79 ( EudraCT Number )
XALCORY 1014 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
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 January 2019

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