Lyrica (Pregabalin) Administered in as an Add-on Therapy for Partial Seizures (LEADER). - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00288639

Purpose

The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.

Condition	Intervention	Phase
Epilepsies, Partial	Drug: Pregabalin	Phase IV

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Lyrica (Pregabalin) Administered In As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentage change in 28-day partial seizure rate at baseline compared to the 12-week treatment observation phase (last 12 weeks of the open-label observation period). [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in partial seizure frequency between the 8 weeks baseline period and the whole 21 weeks open label treatment period, seizure free subjects during the last 12 weeks observation period and the last 4 weeks of the observation period. [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	December 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Pregabalin treatment, given as 2 divided doses, is initiated at a dose of 150 mg/day (75 mg BID).

Based on individual subject response and tolerability, the dosage may be increased to 300 mg/day after 1 week (150 mg BID given as two 75-mg capsules BID). Based on subjects� individual response and tolerability, dosage can be incrementally increased further after an additional week to 600 mg/day (300 mg BID given as four 75-mg capsules BID).

Eligibility

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

Criteria

Inclusion Criteria:

Outpatients > =18 years of age with diagnosed of epilepsy with partial seizures having min 2 partial seizures during a 2 months period before the baseline visit having a clinical history of epilepsy and AED treatment at least 1 yr prior to inclusion

Exclusion Criteria:

AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures having absences seizures having had status epilepticus within the year prior to inclusion Having a progressive neurological or systematic disorder having known significant renal or hepatic dysfunction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288639

Locations

Greece
Pfizer Investigational Site
Thessaloniki, Greece, 57010
Pfizer Investigational Site
Mesogion, Athen, Greece, 15125
Pfizer Investigational Site
Athens, Greece, 11527
Pfizer Investigational Site
Athens, Greece, 11526
Pfizer Investigational Site
Patras, Greece, 26500
Pfizer Investigational Site
Thessaloniki, Greece, 54636
Pfizer Investigational Site
Heraklio, Greece, 71110
Pfizer Investigational Site
Thessaloniki, Greece

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. ( Clinical Trials Disclosure Group )
Study ID Numbers:	A0081088
Study First Received:	February 7, 2006
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00288639 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Pfizer:

Pregabalin for partial seizures

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy
Seizures
Pregabalin
Central Nervous System Diseases

Peripheral Nervous System Agents
Analgesics
Brain Diseases
Anticonvulsants

Additional relevant MeSH terms:

Epilepsies, Partial
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Pregabalin
Brain Diseases
Pharmacologic Actions

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

ClinicalTrials.gov processed this record on May 07, 2009