Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

NCT00288639

Last updated date
Study Location
Pfizer Investigational Site
Athens, , 11526, Greece
Contact
1-800-718-1021

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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

- Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit

- Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion

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


- AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures


- Having absences seizures


- Having had status epileptics within the year prior to inclusion


- Having a progressive neurological or systematic disorder


- Having known significant renal or hepatic dysfunction

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Advanced Information
Descriptive Information
Brief Title  ICMJE Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).
Official Title  ICMJE Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial
Brief Summary The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Drug: Pregabalin

Pregabalin treatment, given as 2 divided doses, is initiated at a dose of 150 mg/day (75 mg BID).

Based on individual subject response and tolerability, the dosage may be increased to 300 mg/day after 1 week (150 mg BID given as two 75-mg capsules BID). Based on subjects individual response and tolerability, dosage can be incrementally increased further after an additional week to 600 mg/day (300 mg BID given as four 75-mg capsules BID).

Study Arms  ICMJE Not Provided
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 Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2009)
98
Original Enrollment  ICMJE
 (submitted: February 7, 2006)
100
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit
  • Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion

Exclusion Criteria:

  • AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures
  • Having absences seizures
  • Having had status epileptics within the year prior to inclusion
  • Having a progressive neurological or systematic disorder
  • Having known significant renal or hepatic dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00288639
Other Study ID Numbers  ICMJE A0081088
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP