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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

Last updated on April 18, 2019

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Study Location
GU Republican Scientific and Practical Center Mother and Child
Minsk, , 220053 Belarus
Contact
1-800-718-1021
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
1-65 month
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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.
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- 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.

NCT01463306
Pfizer
Recruiting
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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