Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

NCT00684424 | Completed Results

• 1 other identifier: A0081213
• Study Type: observational
• Target: 199
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency

  Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase \* 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.

  Baseline through Week 16

Secondary Outcomes (11)

• Antiepileptic Drugs Used in the Past

  Baseline

• Change in 28 Day Partial Seizure Frequency

  Baseline through Week 16 (Final Visit )

• Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study

  Week 8 up to Week 16 (Last 4 weeks of the treatment period)

• Concomitant Drug Treatments

  Baseline through Week 16 (Final Visit)

• Average Dosage of Pregabalin Taken at Baseline and Final Visit

  Baseline, Week 16 (Final Visit )

Study Arms (1)

Outpatients with epilepsy

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Observational Only

Outpatients with epilepsy

Eligibility Criteria

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

Study Population

outpatients

You may qualify if:

• age over 18 years old, patients with epilepsia with partial seizures
• Enrollment to study is fully on physician decision in compliance with current SPC.

You may not qualify if:

• Patient who did not meet indication according to SPC Lyrica

Sponsors & Collaborators

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

Related Links

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

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

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: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 10, 2021
• Results First Posted: June 24, 2010

Record last verified: 2010-05