N/A N=281

Clinical Study With Lyrica In Patients Suffering From Epilepsy

Neuralgia · Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT00922987 ↗

Enrolled (actual)

281

Serious AEs

0.4%

Results posted

Jun 2011

Primary outcome: Primary: Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency — 85.00 Percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Lyrica (pregabalin) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Jun 2010

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	—

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.

Eligibility Criteria

Inclusion Criteria

Adult patients with partial seizures.

Exclusion Criteria

Contraindications according to Summary of Product Characteristics (SmPC).

View full record on ClinicalTrials.gov →

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.