N/A
N=199
Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00684424 ↗Enrolled (actual)
199
Serious AEs
0.5%
Results posted
Jun 2010
Primary outcome: Primary: Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency — 138; 44; 17 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Non-Interventional Study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency |
138; 44; 17 | — |
| SECONDARY Antiepileptic Drugs Used in the Past |
42; 93; 30; 38; 26; 66 | — |
| SECONDARY Change in 28 Day Partial Seizure Frequency |
3.20; 1.339; -1.860 | — |
| SECONDARY Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study |
119; 77; 3 | — |
| SECONDARY Concomitant Drug Treatments |
2; 1; 1; 2; 1; 1 | — |
| SECONDARY Average Dosage of Pregabalin Taken at Baseline and Final Visit |
31; 0; 1; 166; 0; 1 | — |
| SECONDARY Visual Analog Scale of Anxiety (VAS-A) |
47.1; 36.7; 29.0; 29.0 | — |
| SECONDARY Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A) |
-18.2; -18.1 | — |
| SECONDARY Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S) |
28; 77; 39; 31; 14; 9 | — |
| SECONDARY Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C) |
174; 21; 2; 2 | — |
| SECONDARY Medical Outcomes Sleep Scale (MOS-S) |
37.86; 29.1; 18.5; 7.0; 47.51; 35.99 | — |
| SECONDARY Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale |
82; 10; 2; 33; 48; 5 | — |
Summary
The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase
Eligibility Criteria
Inclusion Criteria
- age over 18 years old, patients with epilepsia with partial seizures
- Enrollment to study is fully on physician decision in compliance with current SPC.
Exclusion Criteria
- Patient who did not meet indication according to SPC Lyrica
Data sourced from ClinicalTrials.gov (NCT00684424). 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.