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

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week 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).	8 week baseline period & 12 week treatment observation period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label 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.	8 week baseline period and 21 week treatment period
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.	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.	8 week baseline period and 21 week treatment period
Number of Subjects Seizure-free	Count of subjects seizure free during the period.	last 4 weeks & whole 12 week treatment observation period
Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.	Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period.	8 week baseline observation period & last 4 weeks of observation period
Subjects Achieving Seizure Freedom During Observation Period	Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period.	Day 147 from the first dose of study drug
Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency	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.	8 week baseline observation period & 12 week treatment observation period
Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)	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).	End of 21-week treatment
Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)	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).	End of 21-week treatment
Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores	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.	Baseline, end of 21-week treatment
Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.	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.	Baseline, End of 21-week treatment
Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline	Count of subjects with a weight gain of at least 7 percent relative to baseline.	Baseline, End of 21-week treatment
Subjects Assessment of Optimal Sleep	Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale.	Baseline, End of 21-week treatment

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: February 7, 2006
• First Submitted That Met QC Criteria: February 7, 2006
• First Posted (Estimate): February 8, 2006

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Pregabalin for partial seizures
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081088

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No