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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

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ClinicalTrials.gov Identifier: NCT01463306
Recruitment Status : Active, not recruiting
First Posted : November 1, 2011
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 17, 2011
First Posted Date  ICMJE November 1, 2011
Last Update Posted Date June 17, 2019
Actual Study Start Date  ICMJE February 2012
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2011)
  • SAE's (serious adverse event) and AE's (adverse events) [ Time Frame: continuously for up to one year ]
  • Vital signs [ Time Frame: change from baseline will be assessed at 2, 6, 9 , and 12 months ]
  • Physical exams to assess change from baseline for physical state of limbs, torso, and organs and Neurological exams to assess change from baseline for measures of peripheral and central nervous system function. [ Time Frame: change from baseline will be assessed at 6 and 12 months ]
  • Clinical laboratory data (hematology , chemistry, urinalysis [ Time Frame: change from baseline will be assessed at 6 and 12 months ]
  • Electrocardiograms [ Time Frame: change from baseline will be assessed at 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01463306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2011)
  • Suicidality assessments [ Time Frame: every visit for up to 1 year ]
  • Cognitive testing [ Time Frame: change from baseline will be assessed at 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 14, 2019)
605
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2011)
300
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019

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