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

Viatris

Status and phase

Completed

Phase 3

Conditions

Epilepsy, Partial Seizures

Treatments

Drug: Pregabalin add-on therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01389596

A0081041

XALCORY 1014 (Other Identifier)

2010-020852-79 (EudraCT Number)

Details and patient eligibility

About

Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.

Enrollment

295 patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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.