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

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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:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Pregabalin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Pregabalin


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).



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Number of Subjects Seizure-free [ Time Frame: last 4 weeks & whole 12 week treatment observation period ]
    Count of subjects seizure free during the period.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288639


Locations
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Greece
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00288639     History of Changes
Other Study ID Numbers: A0081088
First Posted: February 8, 2006    Key Record Dates
Results First Posted: July 8, 2009
Last Update Posted: December 6, 2018
Last Verified: November 2018
Keywords provided by Pfizer:
Pregabalin for partial seizures
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs