A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
Condition: Epilepsy, Partial Seizures
MeSH terms: Seizures; Epilepsies, Partial
Intervention: Pregabalin add-on therapy; Pregabalin add-on therapy; Pregabalin add-on therapy
Intervention description: Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.; Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.; Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 295.0
Sex: All
Minimum age: 4 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: safety; efficacy; partial onset seizures; pediatric; pregabalin; placebo-controlled; double-blind

Summary:

      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.
    

Eligibility criteria:

        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.