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This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | pregabalin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Frequency | Baseline up to Week 28 | |
| Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. | Baseline up to Week 28 |
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance. | Baseline up to Week 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Phoenix | Arizona | 85003 | United States | ||
| Pfizer Investigational Site |
Participants were eligible for the current study A0081160 (NCT00596466) if they adequately responded to pregabalin treatment in protocol A0081047 (NCT00524030).
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| Pfizer Investigational Site | Fullerton | California | 92835 | United States |
| Pfizer Investigational Site | Long Beach | California | 90806 | United States |
| Pfizer Investigational Site | Modesto | California | 95355 | United States |
| Pfizer Investigational Site | Murrieta | California | 92562 | United States |
| Pfizer Investigational Site | Newport Beach | California | 92660 | United States |
| Pfizer Investigational Site | Temecula | California | 92591 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80204 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32209 | United States |
| Pfizer Investigational Site | Suwanee | Georgia | 30024 | United States |
| Pfizer Investigational Site | Danville | Indiana | 46122 | United States |
| Pfizer Investigational Site | Fort Wayne | Indiana | 46805 | United States |
| Pfizer Investigational Site | Kansas City | Kansas | 66160 | United States |
| Pfizer Investigational Site | Bowling Green | Kentucky | 42101 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40536 | United States |
| Pfizer Investigational Site | Houma | Louisiana | 70363 | United States |
| Pfizer Investigational Site | Shreveport | Louisiana | 71105-5634 | United States |
| Pfizer Investigational Site | Pikesville | Maryland | 21208 | United States |
| Pfizer Investigational Site | Worcester | Massachusetts | 01608 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48202 | United States |
| Pfizer Investigational Site | Flowood | Mississippi | 39232 | United States |
| Pfizer Investigational Site | Great Falls | Montana | 59405 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28203 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28209 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43210 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Houston | Texas | 77074 | United States |
| Pfizer Investigational Site | Temple | Texas | 76508 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84107 | United States |
| Pfizer Investigational Site | West Jordan | Utah | 84088 | United States |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
| Pfizer Investigational Site | Beroun | 266 01 | Czechia |
| Pfizer Investigational Site | Brno | 602 00 | Czechia |
| Pfizer Investigational Site | Litomyšl | 570 14 | Czechia |
| Pfizer Investigational Site | New Territories | Hong Kong |
| Pfizer Investigational Site | Dnipropetrovsk | 49005 | Ukraine |
| Pfizer Investigational Site | Dnipropetrovsk | 49115 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 61018 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 61068 | Ukraine |
| Pfizer Investigational Site | Luhansk | 91045 | Ukraine |
| Pfizer Investigational Site | Odesa | 65025 | Ukraine |
| Enrolled, Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Seizure Frequency | Not analyzed; Per protocol, seizure frequency data for individual participants were collected and reviewed but no statistical inferences were conducted because there was no comparator agent for this study. | Posted | Baseline up to Week 28 |
|
| ||||||||||||||||||||
| Primary | Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. | Safety analysis set population: all participants who received at least 1 dose of pregabalin. | Posted | Number | Participants | Baseline up to Week 28 |
|
| |||||||||||||||||
| Primary | Number of Participants With Laboratory Test Values of Potential Clinical Importance | Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance. | Safety analysis set population; Number of participants analyzed (N): participants with at least one observation of any given laboratory test while on study. | Posted | Number | Participants | Baseline up to Week 28 |
|
|
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The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment. | 3 | 73 | 14 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Title | Measurements |
|---|---|
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|