Clinical Study With Lyrica In Patients Suffering From Epilepsy

Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Neuralgia
• Intervention / Treatment: Drug: Lyrica (pregabalin)

Detailed Description

- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).

• Study Type: Observational
• Enrollment (Actual): 286

Contacts and Locations

Study Locations

• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Pfizer Investigational Site
  • Banska Bystrica, Slovakia, 97401
    • Pfizer Investigational Site
  • Bardejov, Slovakia, 08501
    • Pfizer Investigational Site
  • Bojnice, Slovakia, 97201
    • Pfizer Investigational Site
  • Bratislava, Slovakia, 81369
    • Pfizer Investigational Site
  • Bratislava, Slovakia, 83103
    • Pfizer Investigational Site
  • Bratislava 1, Slovakia, 80101
    • Pfizer Investigational Site
  • Bratislava 2, Slovakia, 82606
    • Pfizer Investigational Site
  • Bratislava 3, Slovakia, 83305
    • Pfizer Investigational Site
  • Bratislava 4, Slovakia, 84104
    • Pfizer Investigational Site
  • Cadca, Slovakia, 02201
    • Pfizer Investigational Site
  • Dolny Kubin, Slovakia, 02601
    • Pfizer Investigational Site
  • Dubnica nad Vahom, Slovakia, 1841
    • Pfizer Investigational Site
  • Dunajska Streda, Slovakia, 92901
    • Pfizer Investigational Site
  • Handlova, Slovakia, 97251
    • Pfizer Investigational Site
  • Hlohovec, Slovakia, 92001
    • Pfizer Investigational Site
  • Humenne, Slovakia, 06601
    • Pfizer Investigational Site
  • Kemarok, Slovakia, 06001
    • Pfizer Investigational Site
  • Komarno, Slovakia, 94501
    • Pfizer Investigational Site
  • Kosice, Slovakia, 04015
    • Pfizer Investigational Site
  • Kosice 1, Slovakia, 04001
    • Pfizer Investigational Site
  • Kosice 1, Slovakia, 04086
    • Pfizer Investigational Site
  • Kosice 2, Slovakia, 04011
    • Pfizer Investigational Site
  • Kosice 4, Slovakia, 04012
    • Pfizer Investigational Site
  • Kosice 4, Slovakia, 04190
    • Pfizer Investigational Site
  • Krompachy, Slovakia, 05342
    • Pfizer Investigational Site
  • Levice, Slovakia, 93401
    • Pfizer Investigational Site
  • Levoca, Slovakia, 05401
    • Pfizer Investigational Site
  • Liptovsky Mikulas, Slovakia, 03101
    • Pfizer Investigational Site
  • Malacky, Slovakia, 90122
    • Pfizer Investigational Site
  • Martin, Slovakia, 03601
    • Pfizer Investigational Site
  • Martin, Slovakia, 03659
    • Pfizer Investigational Site
  • Modra, Slovakia, 90001
    • Pfizer Investigational Site
  • Myjava, Slovakia, 90713
    • Pfizer Investigational Site
  • Nitra, Slovakia, 94901
    • Pfizer Investigational Site
  • Nove Mesto nad Vahom, Slovakia, 91501
    • Pfizer Investigational Site
  • Nove Zamky, Slovakia, 94034
    • Pfizer Investigational Site
  • Nove Zamky, Slovakia, 94073
    • Pfizer Investigational Site
  • Piestany, Slovakia, 92101
    • Pfizer Investigational Site
  • Poltar, Slovakia, 98701
    • Pfizer Investigational Site
  • Presov, Slovakia, 08001
    • Pfizer Investigational Site
  • Puchov, Slovakia, 2001
    • Pfizer Investigational Site
  • Ruzomberok, Slovakia, 03426
    • Pfizer Investigational Site
  • Ruzomberok, Slovakia, 03401
    • Pfizer Investigational Site
  • Sahy, Slovakia, 93601
    • Pfizer Investigational Site
  • Sered, Slovakia, 92601
    • Pfizer Investigational Site
  • Skalica, Slovakia, 90982
    • Pfizer Investigational Site
  • Snina, Slovakia, 06901
    • Pfizer Investigational Site
  • Spisska Nova Ves, Slovakia, 05201
    • Pfizer Investigational Site
  • Surany, Slovakia, 94218
    • Pfizer Investigational Site
  • Trebisov, Slovakia, 07501
    • Pfizer Investigational Site
  • Trencin, Slovakia, 91101
    • Pfizer Investigational Site
  • Trnava, Slovakia, 91701
    • Pfizer Investigational Site
  • Trnava, Slovakia, 91775
    • Pfizer Investigational Site
  • Trstena, Slovakia, 02801
    • Pfizer Investigational Site
  • Vranov Nad Toplov, Slovakia, 09327
    • Pfizer Investigational Site
  • Zilina, Slovakia, 012 07
    • Pfizer Investigational Site
  • Zilina, Slovakia, 01001
    • Pfizer Investigational Site
  • Zlate Moravce, Slovakia, 95301
    • Pfizer Investigational Site
  • Zvolen, Slovakia, 86001
    • Pfizer Investigational Site
  • Zvolen, Slovakia, 96001
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

• Adult patiens with partial seizures.
• Other inclusion criteria according to Summary of Product Characteristics (SmPC).

Description

Inclusion Criteria:

• Adult patients with partial seizures.

Exclusion Criteria:

• Contraindications according to Summary of Product Characteristics (SmPC).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lyrica; Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics	Drug: Lyrica (pregabalin); The daily dose may range from 150mg to 600mg, administered as two single doses. The treatment should be started with 150mg daily dose (2x75mg). Depending on response and tolerability after 7 days may the dose be increased to 300mg/day (2x150mg) and after further 7 days to maximum dose 600mg/day (2x300mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency	Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.	Baseline through week 16 or early termination (ET)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit	The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit.	Baseline and week 16 or ET
Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study	Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.	Week 4 through week 16 or ET
Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit	VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).	Baseline, week 4 and week 16 or ET
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.	Baseline
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit	The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C). At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse.	Week 16 or ET
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET	MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.	Baseline and week 16 or ET

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Concomitant Drug Treatments	Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study.	Baseline through Week 16 or ET
Number of Participants With Concomitant Co-morbidities	Participants who had a concomitant co-morbidity during the study for any period of time from baseline through to Week 16 (Final Visit); participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable.	Baseline through week 16 or ET

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 17, 2009
• First Submitted That Met QC Criteria: June 17, 2009
• First Posted (Estimate): June 18, 2009

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: lyrica pregabalin epilepsy partial seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Epilepsy; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081236