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

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:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Pregabalin

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 73 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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:


Epilepsies, Partial Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases Gamma-Aminobutyric Acid Pregabalin Analgesics Anticonvulsants Calcium Channel Blockers Cardiovascular Agents	Central Nervous System Agents GABA Agents Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015