Pregabalin Epilepsy Add-On Trial

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.178 enrolled

Overview

To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

178

Conditions

Partial Seizures

Interventions

pregabalinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs * Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures Exclusion Criteria: * Have a treatable cause of seizures * Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)

Locations (5)

Pfizer Investigational Site

Daegu, South Korea

Pfizer Investigational Site

Daejeon, South Korea

Pfizer Investigational Site

Gwangju, South Korea

Pfizer Investigational Site

Incheon, South Korea

Pfizer Investigational Site

Outcomes

Primary Outcomes

Response ratio (RRatio or symmetrized percent change) for all partial seizures

Secondary Outcomes

Responder rate, Percent change, Percent of SGTC responders, Seizure freedom measures, Change in number of seizure-free days (SFD) per a 28-day period, Analysis by seizure type, HADS, Weekly and endpoint mean sleep interference scores from DSIS, QOLIE-31

Data from ClinicalTrials.gov

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