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

Last updated on November 12, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patient who did not meet indication according to SPC Lyrica

NCT00684424
Pfizer
Completed
Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

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Descriptive Information
Brief TitleNon-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Official TitleNon-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Brief SummaryThe 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
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationoutpatients
ConditionEpilepsy
InterventionOther: Non-Interventional Study
Observational Only
Study Groups/CohortsOutpatients with epilepsy
Intervention: Other: Non-Interventional Study
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: May 19, 2009)
199
Original Estimated Enrollment
 (submitted: May 22, 2008)
200
Actual Study Completion DateMarch 2009
Actual Primary Completion DateMarch 2009   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00684424
Other Study ID NumbersA0081213
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2010

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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