NCT00141258

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 22, 2021

Status Verified

April 1, 2009

First QC Date

August 30, 2005

Last Update Submit

January 21, 2021

Conditions

Partial Seizures

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Interventions

pregabalinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Daegu, South Korea

Location

Pfizer Investigational Site

Daejeon, South Korea

Location

Pfizer Investigational Site

Gwangju, South Korea

Location

Pfizer Investigational Site

Incheon, South Korea

Location

Pfizer Investigational Site

Seoul, South Korea

Location

Related Links

MeSH Terms

Conditions

Seizures

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

October 1, 2005

Study Completion

August 1, 2006

Last Updated

January 22, 2021

Record last verified: 2009-04

Locations

KR(5)