A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

NCT01463306

Last updated date
Study Location
Manila Doctors Hospital
Manila, , 1000, Philippines
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, Primary Generalized Tonic-Clonic Seizures Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-66 month
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 dosing and seizure diaries and complete all scheduled visits.

- Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the Screening Visit.

- Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria.

- Partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening.

- 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


- Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy
with Centrotemporal Spikes), and Dravet syndrome,


- A current diagnosis of febrile seizures or any febrile seizure within 1 year of
screening.


- Status epilepticus within 1 year prior to visit 1.


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


- Progressive structural CNS lesion or a progressive encephalopathy.

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Partial Seizures Epilepsy, Primary Generalized Tonic-Clonic Seizures EpilepsyA 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures
NCT01463306
  1. Manila,
  2. Loxahatchee Groves, Florida
  3. Orlando, Florida
  4. Orlando, Florida
  5. Honolulu, Hawaii
  6. San Antonio, Texas
  7. Minsk,
  8. Vitebsk,
  9. Vitebsk,
  10. Brussel, Bruxelles Capitale
  11. Sarajevo, Canton Sarajevo, Bosnia AND Herzegovina
  12. Mostar, Herzegovina-neretva Canton
  13. Prijedor, Republika Srpska
  14. Blagoevgrad,
  15. Pleven,
  16. Plovdiv,
  17. Sofia,
  18. Sofia,
  19. Changchun, Jilin
  20. Shanghai, Shanghai
  21. Shanghai, Shanghai
  22. Bron,
  23. Garches,
  24. Rennes,
  25. Jena, Thueringen
  26. Balassagyarmat,
  27. Budapest,
  28. Budapest,
  29. Budapest,
  30. Budapest,
  31. Kistarcsa,
  32. New Delhi, Delhi
  33. Belagavi, Karnataka
  34. Mangalore, Karnataka
  35. Dhantoli, Nagpur, Maharashtra
  36. Mumbai, Maharashtra
  37. Pune, Maharashtra
  38. Pune, Maharashtra
  39. Kolkata, WEST Bengal
  40. Haifa,
  41. Tel Aviv,
  42. Tel-Aviv,
  43. Seoul,
  44. Seoul,
  45. Beirut,
  46. Beirut,
  47. Kota Bharu, Kelantan
  48. Bijelo Polje,
  49. Cebu City, Cebu
  50. Cebu City, Cebu
  51. Diliman, Quezon City,
  52. Manila,
  53. Manila,
  54. Quezon City,
  55. Swidnik, Lubelskie
  56. Gdansk,
  57. Katowice,
  58. Katowice,
  59. Lublin,
  60. Poznan,
  61. Bucuresti,
  62. Iasi,
  63. Sibiu,
  64. Timisoara,
  65. Pgt. Roshchino, Leningrad Region
  66. Nizhniy Novgorod, Nizhegorodskaya Oblast
  67. Perm, Permskiy KRAY
  68. Pyatigorsk, Stavropol Region
  69. Barnaul,
  70. Moscow,
  71. Moscow,
  72. Moscow,
  73. Perm,
  74. Saint Petersburg,
  75. Saint Petersburg,
  76. Saint Petersburg,
  77. Saint-Petersburg,
  78. Saint-Petersburg,
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  80. Smolensk,
  81. Smolensk,
  82. Smolensk,
  83. Yekaterinburg,
  84. Novi Sad, Vojvodina
  85. Belgrade,
  86. Belgrade,
  87. Kragujevac,
  88. Singapore,
  89. Hlohovec,
  90. Zaragoza,
  91. Kaohsiung,,
  92. Taichung,
  93. Taipei,
  94. Bangkoknoi, Bangkok / Thailand
  95. Ratchathevee, Bangkok
  96. Izmir, Konak Turkey
  97. Eskisehir, Meselik Campus
  98. Izmir, Narlidere
  99. Uncubozköy,
  100. Dnipropetrovsk,
  101. Dnipro,
  102. Ivano-Frankivsk,
  103. Kharkiv,
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  105. Kyiv,
  106. Lviv,
  107. Odesa,
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  109. Uzhgorod,
  110. Zaporizhzhia,
  111. Birmingham, WEST Midlands
  112. Salford,
ALL GENDERS
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Advanced Information
Descriptive Information
Brief Title  ICMJE A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures
Official Title  ICMJE A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
Brief Summary Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy, Partial Seizures
  • Epilepsy, Primary Generalized Tonic-Clonic Seizures
Intervention  ICMJE Drug: Pregabalin
Pregabalin administered as either capsule or liquid oral formulations. Subjects <4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ?4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.
Other Name: Lyrica
Study Arms  ICMJE Experimental: Open
Pregabalin open label flexible dose
Intervention: Drug: Pregabalin
Publications * Not Provided

*   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: June 14, 2019)
605
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2011)
300
Actual Study Completion Date  ICMJE August 22, 2019
Actual Primary Completion Date August 22, 2019   (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 dosing and seizure diaries and complete all scheduled visits.
  • Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the Screening Visit.
  • Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria.
  • Partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening.
  • Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).

Exclusion Criteria:

  • Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy with Centrotemporal Spikes), and Dravet syndrome,
  • A current diagnosis of febrile seizures or any febrile seizure within 1 year of screening.
  • Status epilepticus within 1 year prior to visit 1.
  • Seizures related to drugs, alcohol, or acute medical illness.
  • Progressive structural CNS lesion or a progressive encephalopathy.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Month to 66 Years   (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 Belarus,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   China,   Czechia,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Lebanon,   Malaysia,   Montenegro,   Philippines,   Poland,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Argentina,   Austria,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   Lithuania,   Netherlands,   South Africa
 
Administrative Information
NCT Number  ICMJE NCT01463306
Other Study ID Numbers  ICMJE A0081106
2011-001412-65 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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 2020

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