Clinical trial NCT00288639: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Pregabalin for partial seizures
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-08
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period
timeFrame: 8 week baseline period & 12 week treatment observation period
Secondary outcomes:
measure: Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.
timeFrame: 8 week baseline period and 21 week treatment period
measure: 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.
timeFrame: 8 week baseline period and 21 week treatment period
measure: Number of Subjects Seizure-free
timeFrame: last 4 weeks & whole 12 week treatment observation period
measure: Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.
timeFrame: 8 week baseline observation period & last 4 weeks of observation period
measure: Subjects Achieving Seizure Freedom During Observation Period
timeFrame: Day 147 from the first dose of study drug
measure: Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency
timeFrame: 8 week baseline observation period & 12 week treatment observation period
measure: Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)
timeFrame: End of 21-week treatment
measure: Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)
timeFrame: End of 21-week treatment
measure: Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores
timeFrame: Baseline, end of 21-week treatment
measure: Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.
timeFrame: Baseline, End of 21-week treatment
measure: Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline
timeFrame: Baseline, End of 21-week treatment
measure: Subjects Assessment of Optimal Sleep
timeFrame: Baseline, End of 21-week treatment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Heraklio
country: Greece
facility: Pfizer Investigational Site
city: Mesogion, Athen
country: Greece
facility: Pfizer Investigational Site
city: Patras
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: