NCT00407797

Brief Summary

The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
terminated

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

December 1, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 9, 2010

Completed
Last Updated

January 25, 2021

Status Verified

February 1, 2011

Enrollment Period

2.4 years

First QC Date

December 1, 2006

Results QC Date

August 12, 2010

Last Update Submit

January 21, 2021

Conditions

Partial Seizures

Keywords

LyricaEpilepsies - Partial

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase

    28-day seizure rate (at observation period \[obs\]) = \[(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 \[Week 9\] date)\] \* 28. Percent change = \[(28-day seizure rate obs minus 28-day seizure rate at baseline \[b\]) divided by 28-day seizure rate b\] \* 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.

    Week 9 to Week 21 or End of Treatment (early termination)

Secondary Outcomes (11)

  • Response Ratio (RR)

    Week 9 to Week 21 or End of Treatment (early termination)

  • Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21

    Week 21 or End of Treatment (early termination)

  • Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period

    Week 9 to Week 21 or End of Treatment (early termination)

  • Percent of Seizure- Free Participants During the Treatment Observation Period

    Week 9 to Week 21 or Early Termination (end of treatment)

  • Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period

    Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)

  • +6 more secondary outcomes

Study Arms (1)

Pregabalin

EXPERIMENTAL
Drug: Pregabalin

Interventions

PregabalinDRUG

150 to 600 mg/day during 21 weeks

Pregabalin

Eligibility Criteria

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

You may qualify if:

  • Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.

You may not qualify if:

  • Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pfizer Investigational Site

México, D. F., CP 06700, Mexico

Location

Pfizer Investigational Site

Acapulco de Juárez, Guerrero, 39670, Mexico

Location

Pfizer Investigational Site

Morelia, Michoacán, CP 58000, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64060, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

Pfizer Investigational Site

Aguascalientes, 20127, Mexico

Location

Pfizer Investigational Site

Chihuahua City, 31238, Mexico

Location

Pfizer Investigational Site

Estado de México, CP 52763, Mexico

Location

MeSH Terms

Conditions

SeizuresEpilepsies, Partial

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEpilepsyBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2006

First Posted

December 5, 2006

Study Start

March 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 25, 2021

Results First Posted

September 9, 2010

Record last verified: 2011-02

Locations

ME(8)