Phase 4
Completed N=98
Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).
Source: ClinicalTrials.gov NCT00288639 ↗Enrolled (actual)
98
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period — -33.33 percentage change in events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period |
-33.33 | — |
| SECONDARY Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period. |
-29.39 | — |
| SECONDARY 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. |
-28.12; -22.50; -25.00; -40.00; -58.72; -85.42 | — |
| SECONDARY Number of Subjects Seizure-free |
18; 30 | — |
| SECONDARY Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period. |
42; 33 | — |
| SECONDARY Subjects Achieving Seizure Freedom During Observation Period |
30; 18 | — |
| SECONDARY Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency |
-33.33; -21.99 | — |
| SECONDARY Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC) |
14; 36; 17; 9; 3; 1 | — |
| SECONDARY Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC) |
15; 35; 24; 11; 4; 2 | — |
| SECONDARY Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores |
-3.95; 7.89; -1.82; 0.05; 4.29; 0.52 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21. |
-0.59; -1.68 | — |
| SECONDARY Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline |
8; 2; 2; 1 | — |
| SECONDARY Subjects Assessment of Optimal Sleep |
21; 8; 12; 25 | — |
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
Data sourced from ClinicalTrials.gov (NCT00288639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.