Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00524030 |
Recruitment Status
:
Terminated
(See termination reason in detailed description.)
First Posted
: September 3, 2007
Results First Posted
: May 10, 2012
Last Update Posted
: May 22, 2012
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsies, Partial | Drug: pregabalin 600 mg/day Drug: pregabalin 150 mg/day | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 161 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
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.
|
- 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 ]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%
- 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 ]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 ]
- Percentage of Participants Who Met Protocol-Specified Exit Events [ Time Frame: Week 2 up to Week 18 ]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 ]
- Percentage of Seizure-Free Participants by Study Phase [ Time Frame: Day 1 up to Day 140 ]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 ]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 ]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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524030

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00524030 History of Changes |
Other Study ID Numbers: |
A0081047 |
First Posted: | September 3, 2007 Key Record Dates |
Results First Posted: | May 10, 2012 |
Last Update Posted: | May 22, 2012 |
Last Verified: | May 2012 |
Keywords provided by Pfizer:
Epilepsy partial seizures pregabalin monotherapy double-blind and randomized trial |
Additional relevant MeSH terms:
Epilepsy Seizures Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Pregabalin Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |