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

Purpose

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).

Condition	Intervention	Phase
Epilepsies, Partial Partial Seizure	Drug: Pregabalin	Phase IV

Genetics Home Reference related topics:

autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics:

Epilepsy Seizures

ChemIDplus related topics:

Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
(last 12 wks of the open-label observational period). [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent Change in sleep interference Medical Outcome Sleep (MOS) scale) between the start and the end of the study. [ Time Frame: 21 weeks ] [ Designated as safety issue: Yes ]
Seizure free subjects during the last 12 weeks observation period. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Percent change in Hospital Anxiety and Depression Scale (HADS) between the start and the end of the study. [ Time Frame: 21 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
Percent change in seizure frequency in subjects with <=6 Seizures and in subjects with >6 seizures during the 8 weeks baseline period. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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). [ Time Frame: 21 weeks ] [ Designated as safety issue: Yes ]
Seizure free subjects during the last 4 weeks of the observation period. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Treatment satisfaction given by the patient at the end of the study using subjects global impression of change (Patient General Impression to Change (PGIC)). [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	March 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pregabalin: Experimental	Drug: Pregabalin 150 to 600 mg/day during 21 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407797

Contacts


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

Locations


Mexico
	Pfizer Investigational Site	Active, not recruiting
	Estado de México, Mexico, CP 52763
	Pfizer Investigational Site	Recruiting
	Aguascalientes, Mexico, 20127
	Pfizer Investigational Site	Recruiting
	Chihuahua, Mexico, 31238

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

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

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

Mexico, Nuevo Leon
	Pfizer Investigational Site	Recruiting
	Monterrey, Nuevo Leon, Mexico, 64060
	Pfizer Investigational Site	Recruiting
	Monterrey,, Nuevo Leon, Mexico, 64460

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081090
First Received:	December 1, 2006
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00407797
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Pfizer:

Lyrica

Study placed in the following topic categories:

Epilepsies, Partial

Signs and Symptoms

Epilepsy

Seizures

Pregabalin

Neurologic Manifestations

Central Nervous System Diseases

Brain Diseases

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Anticonvulsants

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00407797