N/A
Completed N=281
Clinical Study With Lyrica In Patients Suffering From Epilepsy
Source: ClinicalTrials.gov NCT00922987 ↗Enrolled (actual)
281
Serious AEs
0.4%
Results posted
Jun 2011
Primary outcomePrimary: Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency — 85.00 Percentage of participants
Summary
Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency |
85.00 | — |
| SECONDARY Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit |
-100.00 | <0.0001 sig |
| SECONDARY Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study |
172 | — |
| SECONDARY Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit |
54.12; -13.60; -26.16 | — |
| SECONDARY Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) |
0; 17; 25; 64; 118; 32 | — |
| SECONDARY Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit |
0; 48; 145; 50; 29; 0 | — |
| SECONDARY Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET |
44.72; 44.55; 44.31; 33.71; 34.41; 6.77 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients with partial seizures.
Exclusion Criteria
- Contraindications according to Summary of Product Characteristics (SmPC).
Data sourced from ClinicalTrials.gov (NCT00922987). 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.