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

August 30, 2007
May 15, 2012
September 2007
April 2011   (final data collection date for primary outcome measure)
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%
The percent of subjects who meet at least one of the 5 pre-specified exit criteria (which reflect a decrease in seizure control) during double-blind treatment.
Complete list of historical versions of study NCT00524030 on ClinicalTrials.gov Archive Site
  • 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.
  • Percent of subjects completing double-blind treatment.
  • Percent of subjects who met each of the exit events.
  • Mean time on pregabalin monotherapy.
  • Percent of subjects seizure-free during: the last study month, the monotherapy phase, and the entire double-blind treatment phase.
  • Pregabalin population PK and exposure-response analysis.
  • Percent of subjects exiting by group.
Not Provided
Not Provided
 
Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Epilepsies, Partial
  • Drug: pregabalin 600 mg/day
    pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
  • Drug: pregabalin 150 mg/day
    pregabalin 150 mg/day (75mg BID), duration is 20 weeks.
  • Experimental: 1
    Intervention: Drug: pregabalin 600 mg/day
  • Experimental: 2
    Intervention: Drug: pregabalin 150 mg/day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
161
June 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Ukraine,   Czech Republic,   Hong Kong
 
NCT00524030
A0081047
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP