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
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any - 65 |
Updated: | 3/27/2019 |
Start Date: | February 21, 2012 |
End Date: | February 29, 2020 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
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
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.
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.
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.
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23
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Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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Pittsburgh, Pennsylvania 15224
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