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
  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
Epilepsy
Drug: Pregabalin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 98
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:
    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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Greece
Pfizer Investigational Site
Athens, Greece, 11527
Pfizer Investigational Site
Athens, Greece, 11526
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00288639     History of Changes
Other Study ID Numbers: A0081088
Study First Received: February 7, 2006
Results First Received: December 16, 2008
Last Updated: August 28, 2009
Health Authority: Greece: National Organization of Medicines

Keywords provided by Pfizer:
Pregabalin for partial seizures

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 29, 2014