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

NCT00288639 | Completed Phase 4 Results

• 1 other identifier: A0081088
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 8

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.

Conditions

Epilepsy

Keywords

Pregabalin for partial seizures

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week 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).

  8 week baseline period & 12 week treatment observation period

Secondary Outcomes (12)

• Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.

  8 week baseline period and 21 week treatment period

• Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period.

  8 week baseline period and 21 week treatment period

• Number of Subjects Seizure-free

  last 4 weeks & whole 12 week treatment observation period

• Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.

  8 week baseline observation period & last 4 weeks of observation period

• Subjects Achieving Seizure Freedom During Observation Period

  Day 147 from the first dose of study drug

Interventions

Pregabalin DRUG

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Having absences seizures
• Having a progressive neurological or systematic disorder
• Having known significant renal or hepatic dysfunction

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (8)

Pfizer Investigational Site

Athens, 11526, Greece

Location

Pfizer Investigational Site

Athens, 11527, Greece

Location

Pfizer Investigational Site

Heraklio, 71110, Greece

Location

Pfizer Investigational Site

Mesogion, Athen, 15125, Greece

Location

Pfizer Investigational Site

Pátrai, 26500, Greece

Location

Pfizer Investigational Site

Thessaloniki, 54636, Greece

Location

Pfizer Investigational Site

Thessaloniki, 57010, Greece

Location

Pfizer Investigational Site

Thessaloniki, Greece

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Epilepsy

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 8, 2006
• Study Start: December 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 22, 2021
• Results First Posted: July 8, 2009

Record last verified: 2018-11

Locations

GR (8)