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Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00596466
First received: January 8, 2008
Last updated: August 10, 2012
Last verified: August 2012
History of Changes

January 8, 2008
August 10, 2012
April 2008
December 2011   (final data collection date for primary outcome measure)
  • Seizure Frequency [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
  • Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: Yes ]
    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
  • Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: Yes ]
    Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.
Seizure frequency data for assessment of efficacy will be summarized. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00596466 on ClinicalTrials.gov Archive Site
Not Provided
The nature, frequency and intensity of adverse events and laboratory abnormalities will be described. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Drug: pregabalin
pregabalin
Experimental: 1
Intervention: Drug: pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completed the previous protocol and wish to continue to receive pregabalin.
  • Diagnosis of epilepsy with partial seizures

Exclusion Criteria:

  • Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Hong Kong,   Ukraine
 
NCT00596466
A0081160
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP