Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
Condition: Epilepsy; Partial Seizure Disorder; Epilepsies, Partial; Complex Partial Seizure Disorder
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial; Epilepsy, Complex Partial
Intervention: Pregabalin; Gabapentin
Intervention description: 150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects; 300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
Intervention MeSH terms: Pregabalin; Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 482.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with
      partial seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects (male or female) must be > 18 years or ≤ 80 years of age, with a diagnosis of
             epilepsy with partial seizures, as defined in the International League Against
             Epilepsy (ILAE) classification of seizures; partial seizures may be simple or complex,
             with or without secondary tonic-clonic generalization.

          -  Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have
             been unresponsive to treatment with at least two but no more than five prior
             antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages
             of 1 or 2 standard AEDs.

          -  They must have had a 12 lead electrocardiogram (ECG) without clinically significant
             abnormal findings prior to randomization.

          -  Subjects must have had magnetic resonance imaging or contrast enhance computed
             tomography scan of the brain that demonstrated no progressive structural central
             nervous system abnormality at the time of the diagnosis of epilepsy.

          -  Women of childbearing potential must be established on an effective method of
             contraception during the study. Women should also have a negative pregnancy test prior
             to study entry.

          -  During the 6-week baseline period, subjects must have had a minimum of four partial
             seizures, with no 28 day period free of partial seizures with or without secondary
             generalization. A caregiver or witness must be with the subject for a sufficient
             duration to accurately chronicle the occurrence of seizures. These seizures must have
             been documented in the subject's diary.

          -  Subjects with electroencephalograph (EEG) testing done within 2 years of
             randomization. EEG abnormalities should be consistent with a diagnosis of focal-onset
             epilepsy.

          -  Signed and dated informed consent will be obtained from each subject (only include
             those able to consent) in accordance with the local regulatory and legal requirements.

          -  Subjects who are willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other trial procedures. Subjects who are willing, but need
             assistance for self administered questionnaires may be considered acceptable, but must
             first be discussed on a case-by-case basis with the Pfizer monitor prior to any to any
             screening tests or procedures for the study.

        Exclusion Criteria:

          -  Females who are pregnant, breastfeeding, or intending to become pregnant during the
             course of the trial.

          -  Subjects with other neurologic illness that could impair endpoint assessment, or
             patients with Lennox-Gastaut syndrome, absence seizures, status epilepticus within the
             12 months prior to study entry, or with seizures due to an underlying medical illness
             or metabolic syndrome.

          -  Subjects with clinically significant liver disease or with a calculated creatinine
             clearance of <60mL/min.

          -  Subjects with a history of lack of response, hypersensitivity or poor tolerability to
             gabapentin or pregabalin.

          -  Previous use of gabapentin or pregabalin within 2 weeks prior to screening or
             likelihood of engaging in these treatments during the study period.

          -  Use of prohibited medications as listed in the protocol in the absence of appropriate
             washout phase or the likelihood of requiring treatment during the study period with
             drugs not permitted by the study protocol.

          -  Participation in any other studies involving investigational or marketed products,
             concomitantly or within 30 days prior to entry in the study.

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with trial participation or
             investigational product administration or may interfere with the interpretation of
             trial results and, in the judgment of the investigator, would make the subject
             inappropriate for entry into this trial.

          -  Subjects who are not suitable to be treated with pregabalin or gabapentin according to
             the respective local labeling.

          -  Subjects with a history of retinal abnormalities or treatment with retinotoxic agents.