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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00524030
First received: August 30, 2007
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Epilepsies, Partial
Drug: pregabalin 600 mg/day
Drug: pregabalin 150 mg/day
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria [ Time Frame: Week 2 up to Week 18 ] [ Designated as safety issue: No ]
    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%


Secondary Outcome Measures:
  • Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria [ Time Frame: Week 2 up to Week 18 ] [ Designated as safety issue: No ]
    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%

  • Percentage of Participants Completing 20 Weeks of Double-Blind Treatment [ Time Frame: Randomization up to Week 20 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Met Protocol-Specified Exit Events [ Time Frame: Week 2 up to Week 18 ] [ Designated as safety issue: No ]
    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

  • Mean Time on Pregabalin Monotherapy [ Time Frame: Week 2 to Week 20 ] [ Designated as safety issue: No ]
  • Percentage of Seizure-Free Participants by Study Phase [ Time Frame: Day 1 up to Day 140 ] [ Designated as safety issue: No ]
    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)

  • Pregabalin Population Pharmacokinetics (PK) [ Time Frame: Baseline up to 20 weeks ] [ Designated as safety issue: No ]
    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.

  • Pregabalin Exposure-Response Analysis [ Time Frame: Day 126 ] [ Designated as safety issue: No ]
    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.


Enrollment: 161
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: pregabalin 600 mg/day
pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
Experimental: 2 Drug: pregabalin 150 mg/day
pregabalin 150 mg/day (75mg BID), duration is 20 weeks.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524030

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Northport, Alabama, United States, 35476
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85003
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
United States, Arkansas
Pfizer Investigational Site
Fayetteville, Arkansas, United States, 72703
United States, California
Pfizer Investigational Site
Fullerton, California, United States, 92835
Pfizer Investigational Site
Long Beach, California, United States, 90806
Pfizer Investigational Site
Modesto, California, United States, 95355
Pfizer Investigational Site
Murrieta, California, United States, 92562
Pfizer Investigational Site
Newport Beach, California, United States, 92660
Pfizer Investigational Site
Temecula, California, United States, 92591
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80204
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32209
Pfizer Investigational Site
Melbourne, Florida, United States, 32901
Pfizer Investigational Site
Miami, Florida, United States, 33126
Pfizer Investigational Site
Miami, Florida, United States, 33136
Pfizer Investigational Site
Sarasota, Florida, United States, 34233
Pfizer Investigational Site
Sarasota, Florida, United States, 34232
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Atlanta, Georgia, United States, 30309
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
Pfizer Investigational Site
Lawrenceville, Georgia, United States, 30045
Pfizer Investigational Site
Suwanee, Georgia, United States, 30024
United States, Indiana
Pfizer Investigational Site
Anderson, Indiana, United States, 46016
Pfizer Investigational Site
Danville, Indiana, United States, 46122
Pfizer Investigational Site
Fort Wayne, Indiana, United States, 46805
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States, 66160
United States, Kentucky
Pfizer Investigational Site
Bowling Green, Kentucky, United States, 42101
Pfizer Investigational Site
Lexington, Kentucky, United States, 40536-0284
Pfizer Investigational Site
Lexington, Kentucky, United States, 40536
United States, Louisiana
Pfizer Investigational Site
Houma, Louisiana, United States, 70363
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71105-5634
United States, Maryland
Pfizer Investigational Site
Pikesville, Maryland, United States, 21208
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01605
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01608
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55422
United States, Mississippi
Pfizer Investigational Site
Flowood, Mississippi, United States, 39232
Pfizer Investigational Site
Hattiesburg, Mississippi, United States, 39401-7246
United States, Montana
Pfizer Investigational Site
Great Falls, Montana, United States, 59405
United States, New York
Pfizer Investigational Site
Cedarhurst, New York, United States, 11516
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28207
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28209
Pfizer Investigational Site
Rocky Mount, North Carolina, United States, 27804
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
Pfizer Investigational Site
Columbus, Ohio, United States, 43210-1250
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16602
Pfizer Investigational Site
Indiana, Pennsylvania, United States, 15701
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38163
Pfizer Investigational Site
Memphis, Tennessee, United States, 38120
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Houston, Texas, United States, 77074-2906
Pfizer Investigational Site
San Antonio, Texas, United States, 78258
Pfizer Investigational Site
Temple, Texas, United States, 76508
United States, Utah
Pfizer Investigational Site
Murray, Utah, United States, 84107
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84107
Pfizer Investigational Site
West Jordan, Utah, United States, 84088
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226
Czech Republic
Pfizer Investigational Site
Beroun, Czech Republic, 266 01
Pfizer Investigational Site
Brno 2, Czech Republic, 602 00
Pfizer Investigational Site
Litomysl, Czech Republic, 570 14
Hong Kong
Pfizer Investigational Site
New Territories, Hong Kong
Ukraine
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49027
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49115
Pfizer Investigational Site
Kharkiv, Ukraine, 61018
Pfizer Investigational Site
Kharkiv, Ukraine, 61068
Pfizer Investigational Site
Lugansk, Ukraine, 91045
Pfizer Investigational Site
Odessa, Ukraine, 65025
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00524030     History of Changes
Other Study ID Numbers: A0081047
Study First Received: August 30, 2007
Results First Received: April 11, 2012
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Epilepsy
partial seizures
pregabalin monotherapy
double-blind and randomized trial

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014