NCT00288639

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-02-08
• Last updated: 2021-01-22
• Results posted: 2009-07-08

Locations

8 sites across 1 country: Greece