Pregabalin Epilepsy Add-On Trial

Pregabalin Add-On Titration Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Partial Seizures

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141258

Enrollment

178

Registered

2005-09-01

Start date

2005-10-31

Completion date

2006-08-31

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Seizures

Brief summary

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

Interventions

DRUGpregabalin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Response ratio (RRatio or symmetrized percent change) for all partial seizures	—

Secondary

Measure	Time frame
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	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026