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Completed

NCT Number: NCT00288639

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Athens, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial

Acronym: LEADER

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 8, 2006
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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