A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
Condition: Generalized Tonic Clonic Seizures
MeSH terms: Seizures
Intervention: Pregabalin Dose Level 1; Pregabalin Dose Level 2; Placebo
Intervention description: Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.; Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.; Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
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: 219.0
Sex: All
Minimum age: 5 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Primary Generalized Tonic Clonic Seizures; Epilepsy; Safety; Efficacy; Tolerability; Pregabalin; Lyrica; Adjunctive treatment; Placebo Controlled; Blinded

Summary:

      The study is designed to evaluate the safety, tolerability and efficacy of two doses of
      pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized
      Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of
      pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC
      seizure frequency and that pregabalin will be safe and well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Seizures classified as Primary Generalized Tonic Clonic Seizures

          -  Must have at least 1 PGTC seizure in the 8 weeks prior to screening

          -  Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1
             PGTC in each 4-week period of the baseline phase

          -  Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments
             (stable within 28 days of screening)

          -  Signed informed consent and assent if a minor

          -  Ability to comply with daily seizure and dosing diary requirements and all study
             procedures

        Exclusion Criteria:

          -  A current diagnosis of febrile seizures, or seizures related to an ongoing acute
             medical illness

          -  Focal seizures (simple partial, complex partial, or partial becoming secondarily
             generalized)

          -  Status Epilepticus within 1 year prior to screening

          -  Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes
             (BECTS) and Dravet syndrome

          -  Seizures related to drugs, alcohol, or acute medical illness

          -  Any change in anti-epileptic treatment regimen (type of medication or dose; VNS
             alteration) within 28 days of the screening visit or during the baseline phase

          -  Progressive or potentially progressive structural CNS lesion or a progressive
             encephalopathy.

          -  Progressive inborn errors of metabolism.