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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00288639
First received: February 7, 2006
Last updated: August 28, 2009
Last verified: August 2009
History of Changes

February 7, 2006
August 28, 2009
December 2005
December 2007   (final data collection date for primary outcome measure)
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period [ Time Frame: 8 week baseline period & 12 week treatment observation period ] [ Designated as safety issue: No ]
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)
Complete list of historical versions of study NCT00288639 on ClinicalTrials.gov Archive Site
  • Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period. [ Time Frame: 8 week baseline period and 21 week treatment period ] [ Designated as safety issue: No ]
  • Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period. [ Time Frame: 8 week baseline period and 21 week treatment period ] [ Designated as safety issue: No ]
  • Number of Subjects Seizure-free [ Time Frame: last 4 weeks & whole 12 week treatment observation period ] [ Designated as safety issue: No ]
  • Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period. [ Time Frame: 8 week baseline observation period & last 4 weeks of observation period ] [ Designated as safety issue: No ]
  • Subjects Achieving Seizure Freedom During Observation Period [ Time Frame: Day 147 from the first dose of study drug ] [ Designated as safety issue: No ]
  • Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency [ Time Frame: 8 week baseline observation period & 12 week treatment observation period ] [ Designated as safety issue: No ]
  • Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC) [ Time Frame: End of 21-week treatment ] [ Designated as safety issue: No ]
  • Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC) [ Time Frame: End of 21-week treatment ] [ Designated as safety issue: No ]
  • Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores [ Time Frame: Baseline, end of 21-week treatment ] [ Designated as safety issue: No ]
  • Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21. [ Time Frame: Baseline, End of 21-week treatment ] [ Designated as safety issue: No ]
  • Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline [ Time Frame: Baseline, End of 21-week treatment ] [ Designated as safety issue: No ]
  • Subjects Assessment of Optimal Sleep [ Time Frame: Baseline, End of 21-week treatment ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).
Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Drug: Pregabalin

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).
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit
  • Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion

Exclusion Criteria:

  • AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures
  • Having absences seizures
  • Having had status epileptics within the year prior to inclusion
  • Having a progressive neurological or systematic disorder
  • Having known significant renal or hepatic dysfunction
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00288639
A0081088
No
Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

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