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Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial

Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsies, Partial; Partial Seizure

Intervention: Pregabalin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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).

Clinical Details

Official title: Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial. A Phase IV Open-Label Trial Using 150,300, 600 mg/Day Of Pregabalin

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Clinical improvement of subjects following adjunctive treatment of pregabalin BID assessed by the percent change from baseline phase in the 28 day seizure rate based on partial seizures recorded during 12 wk treatment observation phase

(last 12 wks of the open-label observational period).

Secondary outcome:

Percent Change in sleep interference Medical Outcome Sleep (MOS) scale) between the start and the end of the study.

Seizure free subjects during the last 12 weeks observation period.

Percent change in Hospital Anxiety and Depression Scale (HADS) between the start and the end of the study.

Responder Rate 50% (Proportion of Subjects with 50% or greater reduction in Seizures frequency between baseline and the final 4 weeks of the observational period.

Responder rate 75% (Proportion of subjects with 75% or greater reduction in seizures frequency between baseline and the final 4 weeks of the observational period.

Treatment satisfaction given by the patient at the end of the study using subjects global impression of change (Patient General Impression to Change (PGIC)).

Percent change in seizure frequency in subjects with <=6 Seizures and in subjects with >6 seizures during the 8 weeks baseline period.

Response ratio (RR) defined to be a comparison between baseline seizure frequency (B) with the 12 week observation phase (F). R Ratio=100x(F-B)/(F+B).

Seizure free subjects during the last 4 weeks of the observation period.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Patients having a treatable cause of seizure, currently receiving vigabatrin, having

a progressive neurological or systemic disorder.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Estado de México CP 52763, Mexico; Active, not recruiting

Pfizer Investigational Site, Aguascalientes 20127, Mexico; Recruiting

Pfizer Investigational Site, Chihuahua 31238, Mexico; Completed

Pfizer Investigational Site, Mexico, D. F. CP 06700, Mexico; Recruiting

Pfizer Investigational Site, Acapulco, Guerrero 39670, Mexico; Recruiting

Pfizer Investigational Site, Morelia, Michoacan CP 58000, Mexico; Recruiting

Pfizer Investigational Site, Monterrey, Nuevo Leon 64060, Mexico; Recruiting

Pfizer Investigational Site, Monterrey,, Nuevo Leon 64460, Mexico; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2007
Ending date: April 2009
Last updated: January 21, 2009

Page last updated: February 12, 2009

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