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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020731-39 | EudraCT Number |
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The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Experimental | Orally-administered pregabalin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Orally-administered pregabalin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE). | An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. | Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as "abnormal" and no abnormalities in the sites were reported as "normal". Any change from the previous physical examination results were noted. |
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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 |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36604 | United States | ||
| University of South Alabama Department of Neurology |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Each participant was restricted to the dose levels that they had previously tolerated, or that had shown acceptable safety and tolerability in study A0081074 (NCT00437281) for the participant's age group.
This study was a dose extension study of pediatric participants with refractory partial-onset seizures who had completed study A0081074 (NCT00437281). Participants were enrolled in 3 countries at 13 study centers with 13 investigators: Republic of Korea (1 center), Mexico (1 center), and the United States (11 centers).
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin: 1-23 Months | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. |
| FG001 | Pregabalin: 2-6 Years |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. |
| Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. | Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined. | Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up |
| Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months). | Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or > 1.25 times upper limit of normal (ULN) or < 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below. | Visit 1 to 12 Months |
| Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months). | Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or > 1.25 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below. | Visit 1 to 12 Months |
| Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months). | Participants with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below. | Visit 1 to 12 Months |
| Derived Body Mass Index Data (BMI) at Month 12/Early Termination. | BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2. | Month 12/Early Termination |
| Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up. | Weight was recorded in kilograms and weight change from Baseline was reported. | Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up |
| Height at Month 12/Early Termination. | Height was recorded in centimeters. | Month 12/Early Termination |
| Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months). | Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF interval (450-<480; 480-<500; ≥500 msec) values were calculated. Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below. | Week 1 to 12 Months |
| Number of Participants With Hematotolgical Abnormalities. | Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10*3/mm*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN. | 12 Months |
| Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy). | Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted. | 12 Months |
| Number of Participants With Abnormalities in Endocrine Panel (Hormones). | Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): <0.8 LLN or >1.2 ULN. | 12 Months |
| Number of Participants With Abnormalities in Creatine Kinase. | Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) (u/L) were noted. | 12 Months |
| Seizure Frequency. | Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE. | 28 Days |
| Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein). | Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section. | 12 Months |
| Mobile |
| Alabama |
| 36693 |
| United States |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
| The Children's Clinica of Jonesboro, P.A | Jonesboro | Arkansas | 72401 | United States |
| Clinical Study Centers, L. L. C. | Little Rock | Arkansas | 72205 | United States |
| UCSF Neurology Clinic | San Francisco | California | 94143 | United States |
| Child Neurology Center of Northwest Florida | Gulf Breeze | Florida | 32561 | United States |
| The Office of Sergio J Jacinto, MD | Tampa | Florida | 33603 | United States |
| Pediatric Epilepsy & Neurology Specialists | Tampa | Florida | 33609 | United States |
| St. John's Clinic | Springfield | Missouri | 65804 | United States |
| St. John's Hospital | Springfield | Missouri | 65804 | United States |
| Women and Children's Hospital of Buffalo | Buffalo | New York | 14222 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Baylor College of Medicine - Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Road Runner Research, Ltd. | San Antonio | Texas | 78258 | United States |
| Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Jalisco | 44280 | Mexico |
| Yonsei University College of Medicine Severance Hospital / Department of Pediatric Neurology | Seoul | 120-752 | South Korea |
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
| FG002 | Pregabalin: 7-11 Years | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
| FG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin: 1-23 Months | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. |
| BG001 | Pregabalin: 2-6 Years | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. |
| BG002 | Pregabalin: 7-11 Years | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
| BG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
| BG004 | 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 | Number of Participants With Adverse Events (AE). | An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | 12 Months |
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| Secondary | Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. | Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as "abnormal" and no abnormalities in the sites were reported as "normal". Any change from the previous physical examination results were noted. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. |
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| Secondary | Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up. | Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up |
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| Secondary | Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months). | Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or > 1.25 times upper limit of normal (ULN) or < 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | Visit 1 to 12 Months |
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| Secondary | Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months). | Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or > 1.25 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | Visit 1 to 12 Months |
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| Secondary | Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months). | Participants with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | Visit 1 to 12 Months |
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| Secondary | Derived Body Mass Index Data (BMI) at Month 12/Early Termination. | BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2. | Safety analysis set: All participants who received at least one dose of study medication were included. Data was available for 15, 11, 10 and 7 participants in Pregabalin 1-23 months group, 2-6 years group, 7-11 years group and 12-16 years group respectively. | Posted | Mean | Standard Deviation | Kg/m^2 | Month 12/Early Termination |
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| Secondary | Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up. | Weight was recorded in kilograms and weight change from Baseline was reported. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Mean | Standard Deviation | Kg | Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up |
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| Secondary | Height at Month 12/Early Termination. | Height was recorded in centimeters. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Mean | Standard Deviation | cm | Month 12/Early Termination |
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| Secondary | Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months). | Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF interval (450-<480; 480-<500; ≥500 msec) values were calculated. Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | Week 1 to 12 Months |
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| Secondary | Number of Participants With Hematotolgical Abnormalities. | Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10*3/mm*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | 12 Months |
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| Secondary | Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy). | Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | 12 Months |
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| Secondary | Number of Participants With Abnormalities in Endocrine Panel (Hormones). | Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): <0.8 LLN or >1.2 ULN. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | 12 Months |
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| Secondary | Number of Participants With Abnormalities in Creatine Kinase. | Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) (u/L) were noted. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | 12 Months |
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| Secondary | Seizure Frequency. | Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | 28 Days |
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| Secondary | Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein). | Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section. | Safety analysis set: All participants who received at least one dose of study medication were included. | Posted | Number | Participants | 12 Months |
|
From Visit 1 to Visit 9 (Follow-up visit)
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 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: 1-23 Months | Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. | 8 | 16 | 14 | 16 | ||
| EG001 | Pregabalin: 2-6 Years | Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. | 3 | 15 | 13 | 15 | ||
| EG002 | Pregabalin: 7-11 Years | Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | 0 | 12 | 11 | 12 | ||
| EG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. | 1 | 11 | 9 | 11 | ||
| EG004 | Overall | This arm summarizes the AE data from all the treatment groups. | 12 | 54 | 47 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Unresponsive to stimuli | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cyclic neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Astigmatism | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Excessive eye blinking | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypermetropia | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Faeces pale | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Crying | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Anal injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Anticonvulsant drug level increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Anger | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dissociation | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dysphemia | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyssomnia | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urine odour abnormal | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Adenoidectomy | Surgical and medical procedures | MedDRA 16.0 | 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 |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Male |
|
| Participants with serious AEs |
|
| Participants with severe AEs |
|
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| OG003 |
| Pregabalin: 12-16 Years |
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| Pregabalin: 12-16 Years |
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day. |
|
|
| OG003 | Pregabalin: 12-16 Years | Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. |
|
|