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

• ClinicalTrials.gov Identifier: NCT00288639
• Recruitment Status: Completed
• First Posted: February 8, 2006
• Results First Posted: July 8, 2009
• Last Update Posted: December 6, 2018
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: February 7, 2006
• First Posted Date: February 8, 2006
• Results First Submitted Date: December 16, 2008
• Results First Posted Date: July 8, 2009
• Last Update Posted Date: December 6, 2018
• Study Start Date: December 2005
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2018)

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 ]

Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).

• Original Primary Outcome Measures (submitted: February 7, 2006): 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)
• Change History: Complete list of historical versions of study NCT00288639 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: November 6, 2018)

• 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 ]
  Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
• 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 ]
  Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
• Number of Subjects Seizure-free [ Time Frame: last 4 weeks & whole 12 week treatment observation period ]
  Count of subjects seizure free during the period.
• 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 ]
  Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period.
• Subjects Achieving Seizure Freedom During Observation Period [ Time Frame: Day 147 from the first dose of study drug ]
  Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period.
• 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 ]
  Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
• Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC) [ Time Frame: End of 21-week treatment ]
  The PGIC is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
• Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC) [ Time Frame: End of 21-week treatment ]
  The CGIC is a clinician's judgment of the overall change in the patient's condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
• Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores [ Time Frame: Baseline, end of 21-week treatment ]
  Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 - 1.
• 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 ]
  Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21.
• 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 ]
  Count of subjects with a weight gain of at least 7 percent relative to baseline.
• Subjects Assessment of Optimal Sleep [ Time Frame: Baseline, End of 21-week treatment ]
  Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale.

• Original Secondary Outcome Measures (submitted: February 7, 2006): 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
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).
• Official Title: Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy

Intervention

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).

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 13, 2009): 98
• Original Enrollment (submitted: February 7, 2006): 100
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Greece

Administrative Information

• NCT Number: NCT00288639
• Other Study ID Numbers: A0081088
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Clinical Trials Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2018