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

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

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Pregabalin

U.S. FDA Resources

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 ]
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 ]
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 ]

Enrollment:	136
Study Start Date:	March 2007
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

Detailed Description:

The study was terminated on 17 March 2009 due to enrollment delay, and considering that it is an open label, single group study. The decision to terminate the trial was not based on any safety concerns, was based on timelines and the difficult to enroll patients.

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

Locations

Mexico
Pfizer Investigational Site
Estado de México, Mexico, CP 52763
Pfizer Investigational Site
Aguascalientes, Mexico, 20127
Pfizer Investigational Site
Chihuahua, Mexico, 31238
Mexico, D. F.
Pfizer Investigational Site
Mexico, D. F., Mexico, CP 06700
Mexico, Guerrero
Pfizer Investigational Site
Acapulco, Guerrero, Mexico, 39670
Mexico, Michoacan
Pfizer Investigational Site
Morelia, Michoacan, Mexico, CP 58000
Mexico, Nuevo Leon
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64060
Pfizer Investigational Site
Monterrey,, Nuevo Leon, Mexico, 64460

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081090
Study First Received:	December 1, 2006
Last Updated:	October 21, 2009
ClinicalTrials.gov Identifier:	NCT00407797 History of Changes
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Pfizer:

Lyrica

Additional relevant MeSH terms:

Epilepsies, Partial
Seizures
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Pregabalin
Brain Diseases
Pharmacologic Actions
Signs and Symptoms

Epilepsy
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010