CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 98 enrolled
Drug / intervention
Pregabalindrug
Likely dose
Pregabalin 150 mg/day initially (75 mg twice daily), titrated up to 300 mg/day (150 mg twice daily) based on response and tolerabilityAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years
  • ✓Diagnosis of epilepsy with partial seizures
  • ✓Minimum 2 partial seizures in 2 months before baseline
  • ✓AED treatment for ≥1 year prior to enrollment
Key exclusion· 5
  • ✕Treatable cause of seizures
  • ✕Absence seizures
  • ✕Status epilepticus within 1 year prior to enrollment
  • ✕Progressive neurological or systemic disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00288639
NCT00288639Phase 4Completed
CompareCT.gov

Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Feb 8, 2006·Updated Jan 22, 2021

In Brief

A Phase 4 clinical trial evaluating Pregabalin for Epilepsy. Completed, enrolled 98 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesGreece
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2006
Enrollment StartDec 1, 2005
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.4 years ago

Interventions

Pregabalindrug

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).