Trial record 1 of 1 for:
NCT00288639
Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER). (LEADER)
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ClinicalTrials.gov Identifier: NCT00288639 |
Recruitment Status :
Completed
First Posted : February 8, 2006
Results First Posted : July 8, 2009
Last Update Posted : January 22, 2021
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Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
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Tracking Information | ||||
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First Submitted Date ICMJE | February 7, 2006 | |||
First Posted Date ICMJE | February 8, 2006 | |||
Results First Submitted Date ICMJE | December 16, 2008 | |||
Results First Posted Date ICMJE | July 8, 2009 | |||
Last Update Posted Date | January 22, 2021 | |||
Study Start Date ICMJE | December 2005 | |||
Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period [ Time Frame: 8 week baseline period & 12 week treatment observation period ] Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).
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Original Primary Outcome Measures ICMJE |
Percentage change in 28-day partial seizure rate at baseline compared to the 12-week treatment observation phase (last 12 weeks of the open-label observation period) | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Change in partial seizure frequency between the 8 weeks baseline period and the whole 21 weeks open label treatment period, seizure free subjects during the last 12 weeks observation period and the last 4 weeks of the observation period | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
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 |
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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). |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
98 | |||
Original Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |