Clinical trial NCT00922987: Clinical Study With Lyrica In Patients Suffering From Epilepsy
Official title: Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuralgia
Epilepsy
Keywords: lyrica pregabalin epilepsy partial seizures
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-18
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Adult patiens with partial seizures.
* Other inclusion criteria according to Summary of Product Characteristics (SmPC).

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* Adult patients with partial seizures.

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency
timeFrame: Baseline through week 16 or early termination (ET)
Secondary outcomes:
measure: Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit
timeFrame: Baseline and week 16 or ET
measure: Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study
timeFrame: Week 4 through week 16 or ET
measure: Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit
timeFrame: Baseline, week 4 and week 16 or ET
measure: Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline
measure: Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
timeFrame: Week 16 or ET
measure: Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
timeFrame: Baseline and week 16 or ET
Other outcomes:
measure: Number of Participants With Concomitant Drug Treatments
timeFrame: Baseline through Week 16 or ET
measure: Number of Participants With Concomitant Co-morbidities
timeFrame: Baseline through week 16 or ET
Locations:
city: Banska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Bardejov
country: Slovakia
facility: Pfizer Investigational Site
city: Bojnice
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava 1
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava 2
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava 3
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava 4
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Cadca
country: Slovakia
facility: Pfizer Investigational Site
city: Dolny Kubin
country: Slovakia
facility: Pfizer Investigational Site
city: Dubnica nad Vahom
country: Slovakia
facility: Pfizer Investigational Site
city: Dunajska Streda
country: Slovakia
facility: Pfizer Investigational Site
city: Handlova
country: Slovakia
facility: Pfizer Investigational Site
city: Hlohovec
country: Slovakia
facility: Pfizer Investigational Site
city: Humenne
country: Slovakia
facility: Pfizer Investigational Site
city: Kemarok
country: Slovakia
facility: Pfizer Investigational Site
city: Komarno
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice 1
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice 1
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice 2
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice 4
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice 4
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Krompachy
country: Slovakia
facility: Pfizer Investigational Site
city: Levice
country: Slovakia
facility: Pfizer Investigational Site
city: Levoca
country: Slovakia
facility: Pfizer Investigational Site
city: Liptovsky Mikulas
country: Slovakia
facility: Pfizer Investigational Site
city: Malacky
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
city: Modra
country: Slovakia
facility: Pfizer Investigational Site
city: Myjava
country: Slovakia
facility: Pfizer Investigational Site
city: Nitra
country: Slovakia
facility: Pfizer Investigational Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: Pfizer Investigational Site
city: Nove Zamky
country: Slovakia
facility: Pfizer Investigational Site
city: Nove Zamky
country: Slovakia
facility: Pfizer Investigational Site
city: Piestany
country: Slovakia
facility: Pfizer Investigational Site
city: Poltar
country: Slovakia
facility: Pfizer Investigational Site
city: Presov
country: Slovakia
facility: Pfizer Investigational Site
city: Puchov
country: Slovakia
facility: Pfizer Investigational Site
city: Ruzomberok
country: Slovakia
facility: Pfizer Investigational Site
city: Ruzomberok
country: Slovakia
facility: Pfizer Investigational Site
city: Sahy
country: Slovakia
facility: Pfizer Investigational Site
city: Sered
country: Slovakia
facility: Pfizer Investigational Site
city: Skalica
country: Slovakia
facility: Pfizer Investigational Site
city: Snina
country: Slovakia
facility: Pfizer Investigational Site
city: Spisska Nova Ves
country: Slovakia
facility: Pfizer Investigational Site
city: Surany
country: Slovakia
facility: Pfizer Investigational Site
city: Trebisov
country: Slovakia
facility: Pfizer Investigational Site
city: Trencin
country: Slovakia
facility: Pfizer Investigational Site
city: Trnava
country: Slovakia
facility: Pfizer Investigational Site
city: Trnava
country: Slovakia
facility: Pfizer Investigational Site
city: Trstena
country: Slovakia
facility: Pfizer Investigational Site
city: Vranov Nad Toplov
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: Zlate Moravce
country: Slovakia
facility: Pfizer Investigational Site
city: Zvolen
country: Slovakia
facility: Pfizer Investigational Site
city: Zvolen
country: Slovakia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: