A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, MULTI-CENTER, COMPARATIVE, FLEXIBLE DOSE TRIAL OF PREGABALIN VERSUS GABAPENTIN AS ADJUNCTIVE THERAPY IN SUBJECTS WITH PARTIAL SEIZURES
- Conditions
- -G40G40
- Registration Number
- PER-115-07
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 19
• Subjects (men or women) must be> 18 years of age or <80 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the seizure classification of the International League Against Epilepsy (ILAE). in English). Partial seizures can be simple or complex, with or without secondary tonic-clonic generalization.
• It is necessary that the subjects have had a diagnosis of epilepsy for at least 2 years and that they have not responded to treatment, with at least two but no more than five antidepileptic drugs (AEDs) above and, At the time of admission to the study, they must be with stable doses of 1 or 2 standard AED.
• They should have had a result without clinically significant findings on a 12-lead electrocardiogram (ECG) before randomization.
• Subjects should have a magnetic resonance imaging or improved contrast-enhanced computed tomography of the brain to demonstrate that there was no progressive structural abnormality of the central nervous system at the time of the diagnosis of epilepsy.
• Women with the potential to have children should establish an effective method for birth control during the study. It is also necessary that women have a negative pregnancy test before entering the study.
• During the 6-week baseline period, subjects must have a minimum of 4 partial seizures, with no 28-day period without partial seizures with or without secondary generalization. It is necessary that a witness or person who attends to hold this with it for enough time to accurately document the presentation of seizures. These convulsions must be documented in the subject´s diary.
• The subjects must have a result of an electroencephalogram (EEG) performed in the two years prior to randomization. Abnormalities in the EEG should be consistent with a diagnosis of focal onset epilepsy.
• The signed and dated informed consent of each subject will be obtained (only those who are able to consent will be included), in accordance with local regulatory and legal requirements.
• Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures. Those subjects who are willing but require help to fill out self-administered questionnaires could be considered acceptable, but each case should be discussed first with the Pfizer monitor before performing any screening test or procedure for the study.
• Women who are pregnant, nursing or who intend to become pregnant during the course of the trial;
• Subjects with other neurological diseases that could affect the evaluation of endpoints or patients with Lennox-Gastaut syndrome, with seizures such as absences, epileptic status in the last 12 months before entering the study or with seizures due to a medical illness or underlying metabolic syndrome;
• Subjects with clinically significant liver disease or creatinine clearance less than 60 mL / mIn;
• Subjects with a history of lack of response, hypersensitivity or poor tolerance to gabapentin or pregabalin;
• Previous use of gabapentin or pregaballna in the two weeks before screening or the possibility of receiving these treatments during the study period;
• Use of prohibited drugs, as noted in the protocol, in the absence of an appropriate washout phase or the likelihood of requiring treatment during the study period with medications that are not allowed in the study protocol;
• Participation in any other study with products under investigation or commercialized, concomitantly or within 30 days prior to entering the study;
• Any other severe acute or chronic, medical or psychiatric condition, or any laboratory abnormality, that could increase the risk associated with participating in the trial or administration of the product under investigation or that could interfere with the interpretation of the study results and that, at the discretion of the Investigator, he could make the subject not appropriate for his Entrance in this essay;
• Subjects that are not appropriate for a treatment with pregabalin or gabapentin, according to the respective local labeling.
• Subjects with a history of retinal abnormalities or treatment with retinotoxic agents.
• If, according to the investigator´s criterion, the subject is not capable or is not likely to follow the protocol, the medication administration procedure or that in any other way, is not appropriate for the study.
• At the discretion of the Investigator, any subject that can not understand the nature, scope, procedures and possible consequences of the study and / or presents some evidence of uncooperative behavior.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:calculated as the percentage change in seizure frequency over 28 days during the treatment maintenance phase, compared to the baseline.<br>Measure:change in the frequency of seizures from the baseline to the end point<br>Timepoints:28 days<br>
- Secondary Outcome Measures
Name Time Method