Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
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This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.
Seizure Frequency [ Time Frame: Baseline up to Week 28 ]
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 28 ]
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline up to Week 28 ]
Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Completed the previous protocol and wish to continue to receive pregabalin.
Diagnosis of epilepsy with partial seizures
Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
Additional relevant MeSH terms:
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Central Nervous System Depressants