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This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Active Comparator |
| |
| A | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | 300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Response to Treatment | Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28. | Baseline up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in 28 Day Seizure Frequency at Week 16 | The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. | Baseline, Week 16 |
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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 | Duffel | B-2570 | Belgium | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24902473 | Derived | Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin 75 milligram (mg) capsule orally twice daily (BID) for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the titration phase (TP). If seizure control was inadequate (adequate: at least [>=] 50% reduction in seizures), pregabalin dose was escalated to 225 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week maintenance phase(MP). Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during TP and MP. After MP, participants were allowed to progress into optional (opt) blinded continuation phase, and remained on dose from MP for a maximum of 2 years or until last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| levetiracetam | Drug | 1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects |
|
| Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16 | Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures. | Baseline, Week 16 |
| Percentage of Participants Without Seizures | Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure. | Baseline up to Week 16 |
| Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up | BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment. | Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase) |
| Hospital Anxiety and Depression Scale (HADS) Score | HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. | Baseline, Week 16 |
| Medical Outcomes Study Sleep Scale (MOS-SS) Score | Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute. | Baseline, Week 16 |
| Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported. | Baseline, Week 16 |
| Yvoir |
| B-5530 |
| Belgium |
| Pfizer Investigational Site | Kyustendil | Bulgaria |
| Pfizer Investigational Site | Pernik | 2300 | Bulgaria |
| Pfizer Investigational Site | Plovdiv | 4000 | Bulgaria |
| Pfizer Investigational Site | Rousse | Bulgaria |
| Pfizer Investigational Site | Sofia | 1113 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1407 | Bulgaria |
| Pfizer Investigational Site | Barranquilla | Atlántico | 0 | Colombia |
| Pfizer Investigational Site | Bogota | Cundinamarca | 0 | Colombia |
| Pfizer Investigational Site | Montes de Oca | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | San José | Costa Rica |
| Pfizer Investigational Site | Brno | 602 00 | Czechia |
| Pfizer Investigational Site | Hradec Králové | 500 03 | Czechia |
| Pfizer Investigational Site | Olomouc | 775 20 | Czechia |
| Pfizer Investigational Site | Ostrava-Trebovice | 772 00 | Czechia |
| Pfizer Investigational Site | Prague | 140 59 | Czechia |
| Pfizer Investigational Site | PÅ™Ãbram | 26195 | Czechia |
| Pfizer Investigational Site | Rychnov nad Kněžnou | 516 01 | Czechia |
| Pfizer Investigational Site | Strasbourg | 67091 | France |
| Pfizer Investigational Site | Toulouse | 31043 | France |
| Pfizer Investigational Site | Bonn | 53105 | Germany |
| Pfizer Investigational Site | Hamburg | 22083 | Germany |
| Pfizer Investigational Site | Athens | 11521 | Greece |
| Pfizer Investigational Site | Thessaloniki | 57010 | Greece |
| Pfizer Investigational Site | Pune | Maharashtra | 411 004 | India |
| Pfizer Investigational Site | Chandigarh | Punjab | 160 012 | India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141 008 | India |
| Pfizer Investigational Site | Florence | 50125 | Italy |
| Pfizer Investigational Site | Foggia | 71100 | Italy |
| Pfizer Investigational Site | Pisa | 56126 | Italy |
| Pfizer Investigational Site | Siena | 53100 | Italy |
| Pfizer Investigational Site | Kaunas | 50009 | Lithuania |
| Pfizer Investigational Site | Vilnius | 08661 | Lithuania |
| Pfizer Investigational Site | Distrito Federal | 14269 | Mexico |
| Pfizer Investigational Site | San Luis Potosà City | 78223 | Mexico |
| Pfizer Investigational Site | Panama City | Panama |
| Pfizer Investigational Site | Lima | L 11 | Peru |
| Pfizer Investigational Site | Lima | Lima 1 | Peru |
| Pfizer Investigational Site | Tondo | Manila | 1000 | Philippines |
| Pfizer Investigational Site | Cebu City | 6000 | Philippines |
| Pfizer Investigational Site | Davao City | 8000 | Philippines |
| Pfizer Investigational Site | Makati City | 1200 | Philippines |
| Pfizer Investigational Site | Manila | 1000 | Philippines |
| Pfizer Investigational Site | Quezon City | 1100 | Philippines |
| Pfizer Investigational Site | Moscow | 107150 | Russia |
| Pfizer Investigational Site | Moscow | 125367 | Russia |
| Pfizer Investigational Site | Moscow | 129128 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 194044 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 194354 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 197022 | Russia |
| Pfizer Investigational Site | Busan | 602-715 | South Korea |
| Pfizer Investigational Site | Daejeon | 301-721 | South Korea |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Pfizer Investigational Site | Seoul | 120-752 | South Korea |
| Pfizer Investigational Site | Seoul | 135-710 | South Korea |
| Pfizer Investigational Site | Seoul | 137-701 | South Korea |
| Pfizer Investigational Site | Seoul | 138-736 | South Korea |
| Pfizer Investigational Site | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Pfizer Investigational Site | Alicante | 03010 | Spain |
| Pfizer Investigational Site | Barcelona | 08035 | Spain |
| Pfizer Investigational Site | Córdoba | 14008 | Spain |
| Pfizer Investigational Site | Girona | 17007 | Spain |
| Pfizer Investigational Site | Seville | 41071 | Spain |
| Pfizer Investigational Site | Kaohsiung City | 807 | Taiwan |
| Pfizer Investigational Site | Taichung | 407 | Taiwan |
| Pfizer Investigational Site | Tainan | 704 | Taiwan |
| Pfizer Investigational Site | Çapa | Istanbul | 34390 | Turkey (Türkiye) |
| Pfizer Investigational Site | Ankara | 06100 | Turkey (Türkiye) |
| Pfizer Investigational Site | Cerrahpasa / Istanbul | 34098 | Turkey (Türkiye) |
| Pfizer Investigational Site | Caracas | Libertador | 1010 | Venezuela |
| Pfizer Investigational Site | Caracas | Miranda | 1080-A | Venezuela |
| FG001 | Levetiracetam | Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. |
| Completed Titration Phase |
|
| Completed Maintenance Phase |
|
| Entered Opt Blinded Continuation Phase |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period. |
| BG001 | Levetiracetam | Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| 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 | Proportion of Participants With Response to Treatment | Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28. | Per protocol population included all randomized participants who had at least 28 days of study drug during the maintenance phase and a minimum of 28 days of utilizable seizure diary data during baseline and maintenance phases of the study and had no major protocol violation. | Posted | Number | proportion of participants | Baseline up to Week 16 |
|
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| Secondary | Percent Change From Baseline in 28 Day Seizure Frequency at Week 16 | The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. | Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. | Posted | Median | Full Range | percent change | Baseline, Week 16 |
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| Secondary | Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16 | Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures. | SGTC population included all participants who had at least 1 SGTC seizure during either baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively. | Posted | Mean | Standard Deviation | percentage of all partial seizure/28days | Baseline, Week 16 |
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| Secondary | Percentage of Participants Without Seizures | Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure. | FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Week 16 |
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| Secondary | Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up | BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment. | FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hospital Anxiety and Depression Scale (HADS) Score | HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. | FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Medical Outcomes Study Sleep Scale (MOS-SS) Score | Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute. | FAS included all randomized participants who had received at least 1 blinded dose of study medication and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported. | FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively. | Posted | Number | percentage of participants | Baseline, Week 16 |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| 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 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period. | 24 | 254 | 148 | 254 | ||
| EG001 | Levetiracetam | Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. | 24 | 255 | 127 | 255 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Drowning | General disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Polyp | General disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Retroperitoneal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.1 | Non-systematic Assessment |
| |
| Complex partial seizures | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Drug withdrawal convulsions | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Postictal state | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v15.1 | Non-systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA v15.1 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Personality disorder | Psychiatric disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Somatoform disorder neurologic | Psychiatric disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v15.1 | Non-systematic Assessment |
|
Results for BPRS were provided as change in scores at Week 16 compared to baseline instead of absolute scores as per planned analysis.
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 |
|---|---|
| D012640 | Seizures |
| D004828 | Epilepsies, Partial |
| D017029 | Epilepsy, Complex Partial |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000077287 | Levetiracetam |
| 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 |
| D000081 | Acetamides |
| D000577 | Amides |
| D000085 | Acetates |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Levetiracetam |
Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. |
|
|
|
| OG001 | Levetiracetam | Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. |
|
|
| OG001 | Levetiracetam | Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. |
|
|
|
| OG001 | Levetiracetam | Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. |
|
|
|
| OG001 | Levetiracetam | Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. |
|
|
|
| OG001 | Levetiracetam | Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. |
|
|
|
| OG001 | Levetiracetam | Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. |
|
|
|