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NCT00524030 Clinical Trial

Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Epilepsies, Partial Clinical Trial

Official title:
A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00524030
Other study ID # A0081047
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 2007
Est. completion date June 2011

Study information
Verified date December 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

Description:

After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.

Recruitment information / eligibility
Status Terminated
Enrollment 161
Est. completion date June 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of epilepsy with partial seizures. - Males or females, age 18 years or older. - Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit. - Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit. Exclusion Criteria: - Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event. - Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin. - Primary generalized epilepsy or status epilepticus within the previous year.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• pregabalin 600 mg/day
pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
• pregabalin 150 mg/day
pregabalin 150 mg/day (75mg BID), duration is 20 weeks.

Locations
Country Name City State
Czechia Pfizer Investigational Site Beroun
Czechia Pfizer Investigational Site Brno 2
Czechia Pfizer Investigational Site Litomysl
Hong Kong Pfizer Investigational Site New Territories
Ukraine Pfizer Investigational Site Dnipropetrovsk
Ukraine Pfizer Investigational Site Dnipropetrovsk
Ukraine Pfizer Investigational Site Kharkiv
Ukraine Pfizer Investigational Site Kharkiv
Ukraine Pfizer Investigational Site Lugansk
Ukraine Pfizer Investigational Site Odessa
United States Pfizer Investigational Site Altoona Pennsylvania
United States Pfizer Investigational Site Anderson Indiana
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Bowling Green Kentucky
United States Pfizer Investigational Site Cedarhurst New York
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Danville Indiana
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site Fayetteville Arkansas
United States Pfizer Investigational Site Flowood Mississippi
United States Pfizer Investigational Site Fort Wayne Indiana
United States Pfizer Investigational Site Fullerton California
United States Pfizer Investigational Site Great Falls Montana
United States Pfizer Investigational Site Hattiesburg Mississippi
United States Pfizer Investigational Site Houma Louisiana
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Indiana Pennsylvania
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Kansas City Kansas
United States Pfizer Investigational Site Lawrenceville Georgia
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Long Beach California
United States Pfizer Investigational Site Melbourne Florida
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site Modesto California
United States Pfizer Investigational Site Murray Utah
United States Pfizer Investigational Site Murrieta California
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Newport Beach California
United States Pfizer Investigational Site Northport Alabama
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Pikesville Maryland
United States Pfizer Investigational Site Rocky Mount North Carolina
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Sarasota Florida
United States Pfizer Investigational Site Sarasota Florida
United States Pfizer Investigational Site Shreveport Louisiana
United States Pfizer Investigational Site Sun City Arizona
United States Pfizer Investigational Site Suwanee Georgia
United States Pfizer Investigational Site Temecula California
United States Pfizer Investigational Site Temple Texas
United States Pfizer Investigational Site West Jordan Utah
United States Pfizer Investigational Site Worcester Massachusetts
United States Pfizer Investigational Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Hong Kong,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100% Week 2 up to Week 18
Secondary Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP >2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) * 100% Week 2 up to Week 18
Secondary Percentage of Participants Completing 20 Weeks of Double-Blind Treatment Randomization up to Week 20
Secondary Percentage of Participants Who Met Protocol-Specified Exit Events Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP >2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP >2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity Week 2 up to Week 18
Secondary Mean Time on Pregabalin Monotherapy Week 2 to Week 20
Secondary Percentage of Seizure-Free Participants by Study Phase Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140) Day 1 up to Day 140
Secondary Pregabalin Population Pharmacokinetics (PK) Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. Baseline up to 20 weeks
Secondary Pregabalin Exposure-Response Analysis Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates. Day 126
See also
  Status Clinical Trial Phase
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Completed NCT00771927 - Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures N/A
Completed NCT00236873 - A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures. Phase 2
Completed NCT01745952 - Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS) N/A
Completed NCT00772603 - Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures Phase 3
Completed NCT00280696 - A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures Phase 3
Completed NCT00643136 - A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures Phase 3
Completed NCT00230698 - A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure Phase 3
Completed NCT00072813 - MRI in Autosomal Dominant Partial Epilepsy With Auditory Features N/A
Enrolling by invitation NCT04309812 - Transcranial Direct Current to Treat Epilepsy at Home Early Phase 1
Completed NCT00620555 - A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures Phase 3
Withdrawn NCT00422110 - A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures Phase 2/Phase 3
Completed NCT00448916 - Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures Phase 3
Completed NCT00210522 - An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy Phase 2
Completed NCT00236886 - Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients Phase 3
Completed NCT00236860 - A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures Phase 2
Active, not recruiting NCT03689114 - Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) Phase 4
Completed NCT01098162 - Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug N/A
Completed NCT05273398 - Effects of Diazepam on RNS Detections Phase 4
Completed NCT00918047 - Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients Phase 1

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