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

Last updated on March 14, 2019

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Study Location
Center for Neurosciences
Tucson, Arizona, 85718 United States
Contact
1-800-718-1021
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.
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- 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.
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- 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.

NCT01389596
Pfizer
Completed
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years

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