Phase 3 N=660 Randomized Triple-blind Treatment

Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy

Epilepsy, Partial

Bottom Line

View on ClinicalTrials.gov: NCT00280059 ↗

Enrolled (actual)

660

Serious AEs

11.5%

Results posted

Oct 2011

Primary outcome: Primary: Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase — 51.6; 67.9 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pregabalin (Drug); Lamotrigine (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase	51.6; 67.9	—
SECONDARY Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures	254; 183	0.0034 sig
SECONDARY Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)	33; 31	0.8047
SECONDARY Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)	94; 80	0.2537
SECONDARY Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase	78; 58	0.0025 sig
SECONDARY Exit Due to Any Reason After 4-week Dose Escalation Phase	78; 58	0.0744
SECONDARY Time to First Seizure After the 4-Week Dose Escalation Phase	85; 211	0.0003 sig
SECONDARY Median Monthy Seizure Frequency: All Partial Seizures	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Mean Monthy Seizure Frequency: All Partial Seizures	2.56; 5.08; 2.23; 4.21; 1.18; 3.21	—
SECONDARY Median Monthy Seizure Frequency: All Seizures	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Mean Monthy Seizure Frequency: All Seizures	2.74; 5.10; 2.31; 4.24; 1.53; 3.22	—
SECONDARY Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures	0.19; 0.04; 0.28; 0.03; 0.05; 0.07	—
SECONDARY Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures	0.19; 0.05; 0.28; 0.03; 0.07; 0.07	—
SECONDARY Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group	70.5; 59.7; 20.4; 13.0; 80.5; 67.9	—
SECONDARY Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)	-0.3; -1.1; -0.1; -0.7	0.0025 sig
SECONDARY Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale	195; 173; 103; 126; 167; 155	0.0683

Summary

The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.

Eligibility Criteria

Inclusion Criteria

Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months.

Exclusion Criteria

Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin.
Primary generalized seizures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00280059). 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.