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

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NCT00288639

Last updated on December 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Athens, , 11526 Greece
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT00288639
Pfizer
Completed
Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

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Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).
Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Epilepsy
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).
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
December 2007
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT00288639
A0081088
No
Not Provided
Not Provided
Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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