Pregabalin In Partial Seizures Extension Study - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143130

Purpose

To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.

Condition	Intervention	Phase
Seizures	Drug: Pregabalin	Phase III

MedlinePlus related topics: Seizures

Drug Information available for: Pregabalin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-Month Follow-on Open-Label, International, Multicenter Add-on Therapy Trial

Further study details as provided by Pfizer:

Primary Outcome Measures:

Reduction in seizure frequency. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Seizure-free patients during each 3-month period [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures). [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures). [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Arms	Assigned Interventions
Single Arm: Experimental	Drug: Pregabalin Pregabalin

Eligibility

Criteria

Inclusion Criteria:

met the inclusion/exclusion criteria for A0081005
have completed the 21-week study and have shown a significant clinical response and wish to continue treatment

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143130

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Clinical Trials Disclosure Group )
Study ID Numbers:	A0081015
Study First Received:	August 31, 2005
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00143130
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Pfizer:

phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica

Study placed in the following topic categories:

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 January 16, 2009