A Phase 3 interventional study of Pregabalin in Epilepsies, Partial, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 18 sites in 3 countries. Open to participants aged 1 Month to 16 Years. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 54 is close to the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Orally-administered pregabalin
Drug: Pregabalin
Orally-administered pregabalin
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.
Time frame: 12 Months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 Months
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).
| Milestone | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Started | 16 | 15 | 12 | 11 |
| Completed | 9 | 9 | 6 | 5 |
| Not completed | 7 | 6 | 6 | 6 |
| Withdrew: Adverse event | 2 | 2 | 3 | 2 |
| Withdrew: Lack of efficacy | 1 | 0 | 2 | 1 |
| Withdrew: Withdrawal by subject | 3 | 3 | 1 | 1 |
| Withdrew: Other | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 1 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Participants with AEs | 14 | 13 | 11 | 9 |
| Participants with serious AEs | 8 | 3 | 0 | 1 |
| Participants with severe AEs | 7 | 4 | 0 | 1 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Week 1 (N=16,13,11,10) | 2 | 1 | 0 | 0 |
| Month 1 (N=14,13,10,10) | 1 | 1 | 0 | 0 |
| Month 6 (N=11,10,6,7) | 1 | 1 | 0 | 0 |
| Month 12/Eary Termination (N=16,12,12,9) | 1 | 2 | 1 | 1 |
| Follow-up (N=6,4,9,6) | 0 | 0 | 1 | 0 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Week 1 (N=16,13,11,10) | 1 | 0 | 0 | 0 |
| Month 1 (N=14,13,10,10) | 0 | 0 | 0 | 0 |
| Month 6 (N=11,10,6,7) | 0 | 0 | 0 | 0 |
| Month 12/Early Termination (N=16,11,12,9) | 0 | 0 | 0 | 0 |
| Follow-up (N=6,4,9,6) | 0 | 0 | 0 | 0 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| ≥ 20% increase from Baseline | 12 | 5 | 8 | 3 |
| ≥ 20% decrease from Baseline | 5 | 7 | 3 | 3 |
| > 1.25 * ULN | 1 | 1 | 0 | 0 |
| < 0.9 * LLN | 0 | 0 | 3 | 0 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| ≥ 30% increase from Baseline | 2 | 3 | 1 | 1 |
| ≥ 30% decrease from Baseline | 2 | 1 | 0 | 0 |
| > 1.25 * ULN | 0 | 0 | 0 | 0 |
| < 0.9 * LLN | 0 | 0 | 1 | 0 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| > 1.5 * ULN | 0 | 0 | 0 | 0 |
| < 0.9 * LLN | 5 | 2 | 1 | 0 |
BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2.
| Kg/m^2 | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Derived Body Mass Index Data (BMI) at Month 12/Early Termination. | 16.2 ± 1.73 | 18.0 ± 3.52 | 20.6 ± 6.52 | 24.8 ± 7.72 |
Weight was recorded in kilograms and weight change from Baseline was reported.
| Kg | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Day 9 (N=16,14,12,11) | 0.1 ± 0.16 | 0.1 ± 0.29 | -0.1 ± 0.79 | 0.4 ± 1.07 |
| Week 1 (N=16,13,11,10) | 0.3 ± 0.29 | 0.4 ± 0.61 | 1.5 ± 1.15 | 1.2 ± 1.43 |
| Month 1 (N=14,13,10,10) | 0.4 ± 0.45 | 0.8 ± 0.73 | 2.1 ± 1.77 | 2.4 ± 1.52 |
| Month 2 (N=11,12,8,9) | 1.0 ± 0.73 | 1.2 ± 1.12 | 3.8 ± 3.25 | 3.0 ± 1.81 |
| Month 4 (N=11,10,7,9) | 1.3 ± 0.86 | 1.3 ± 1.29 | 5.2 ± 4.32 | 4.1 ± 2.28 |
| Month 6 (N=11,10,6,7) | 1.8 ± 0.98 | 1.4 ± 1.52 | 5.9 ± 4.17 | 5.9 ± 3.32 |
| Month 9 (N=9,10,6,5) | 2.4 ± 1.18 | 2.3 ± 2.52 | 6.3 ± 4.66 | 7.3 ± 4.32 |
| Month 12/Early Termination (N=15,12,11,8) | 1.8 ± 1.33 | 2.4 ± 2.71 | 6.0 ± 4.78 | 6.6 ± 4.51 |
Height was recorded in centimeters.
| cm | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Height at Month 12/Early Termination. | 83.3 ± 8.87 | 109.9 ± 12.76 | 145.6 ± 13.21 | 167.3 ± 8.18 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| PR interval: ≥ 200 msec | 0 | 0 | 0 | 0 |
| PR interval: ≥50% increase from Baseline | 0 | 0 | 0 | 0 |
| PR interval: ≥25% increase from Baseline | 1 | 0 | 1 | 0 |
| QRS interval: ≥ 200 msec | 0 | 0 | 0 | 0 |
| QRS interval: ≥25% increase from Baseline | 0 | 0 | 0 | 0 |
| QT interval: ≥ 500 msec | 0 | 0 | 0 | 0 |
| QTcB interval: 450-<480 msec | 1 | 1 | 1 | 2 |
| QTcB interval: 480-<500 msec | 0 | 0 | 0 | 0 |
| QTcB interval: ≥ 500 msec | 0 | 0 | 0 | 0 |
| QTcF interval: 450-<480 msec | 0 | 0 | 0 | 0 |
| QTcF interval: 480-<500 msec | 0 | 0 | 0 | 0 |
| QTcF interval: ≥ 500 msec | 0 | 0 | 0 | 0 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Platelets: <0.5xLLN (N=16,15,12,11) | 1 | 1 | 0 | 0 |
| Platelets: >1.75xULN (N=16,15,12,11) | 1 | 0 | 0 | 0 |
| WBC count: <0.6xLLN (N=15,15,12,11) | 1 | 2 | 0 | 0 |
| WBC count: >1.5xULN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Lymphocytes-Abs: <0.8xLLN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Lymphocytes-Abs: >1.2xULN (N=15,15,12,11) | 1 | 0 | 0 | 2 |
| Total neutrophils-Abs: <0.8xLLN (N=15,15,12,11) | 3 | 4 | 3 | 3 |
| Total neutrophils-Abs: >1.2xULN (N=15,15,12,11) | 1 | 1 | 0 | 0 |
| Eosinophils-Abs: >1.2xULN (N=15,15,12,11) | 3 | 1 | 1 | 0 |
| Hemoglobin: <0.8xLLN(N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Hematocrit: <0.8xLLN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Red blood cell count: <0.8xLLN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Basophils: >1.2xULN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Monocytes: >1.2xULN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy). | 1 | 1 | 0 | 1 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| T4 (free): <0.8xLLN (N=13,13,11,10) | 0 | 1 | 0 | 0 |
| T4 (free): >1.2xULN (N=13,13,11,10) | 0 | 0 | 0 | 0 |
| TSH: <0.8xLLN (N=14,12,11,10) | 1 | 0 | 0 | 0 |
| TSH: >1.2xULN (N=14,12,11,10) | 0 | 0 | 0 | 0 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Number of Participants With Abnormalities in Creatine Kinase. | 0 | 1 | 1 | 4 |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Seizure Frequency. | NA | NA | NA | NA |
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.
| Participants | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years |
|---|---|---|---|---|
| Alanine Aminotransferase: >3.0xULN (N=15,15,12,11) | 0 | 1 | 1 | 0 |
| Blood Urea Nitrogen: >1.3xULN | 2 | 5 | 1 | 0 |
| Albumin: <0.8xLLN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Albumin: >1.2xULN (N=15,15,12,11) | 2 | 0 | 0 | 0 |
| Potassium: <0.9xLLN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Potassium: >1.1xULN (N=15,15,12,11) | 1 | 0 | 1 | 0 |
| Magnesium: <0.9xLLN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Magnesium: >1.1xULN (N=15,15,12,11) | 1 | 2 | 0 | 1 |
| Phosphate: <0.8xLLN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Phosphate: >1.2xULN (N=15,15,12,11) | 0 | 1 | 1 | 0 |
| Bicarbonate (venous): <0.9xLLN (N=15,15,12,11) | 9 | 11 | 7 | 3 |
| Bicarbonate (venous): >1.1xULN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Glucose: <0.6xLLN (N=15,15,12,11) | 1 | 1 | 0 | 0 |
| Glucose: >1.5xULN (N=15,15,12,11) | 0 | 0 | 0 | 0 |
| Insulin-like GrowthFactor:<0.9xLLN(N=12,13,11,10) | 0 | 0 | 1 | 0 |
| Insulin-like GrowthFactor:>1.1xULN(N=12,13,11,10) | 5 | 8 | 4 | 6 |
| IGF Binding Protein: <0.9xLLN (N=12,13,11,10) | 0 | 0 | 0 | 0 |
| IGF Binding Protein: >1.1xULN (N=12,13,11,10) | 4 | 2 | 5 | 0 |
| Lipid profile cholesterol/triglycerides(N=1,4,0,1) | 0 | 0 | 0 | 0 |
Collected over From Visit 1 to Visit 9 (Follow-up visit). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin: 1-23 Months | — | 8/16 (50%) | 14/16 (87.5%) |
| Pregabalin: 2-6 Years | — | 3/15 (20%) | 13/15 (86.7%) |
| Pregabalin: 7-11 Years | — | 0/12 (0%) | 11/12 (91.7%) |
| Pregabalin: 12-16 Years | — | 1/11 (9.1%) | 9/11 (81.8%) |
| Overall | — | 12/54 (22.2%) | 47/54 (87%) |
| Event | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years | Overall |
|---|---|---|---|---|---|
| ConvulsionNervous system disorders | 3/16 | 0/15 | 0/12 | 0/11 | 3/54 |
| Unresponsive to stimuliNervous system disorders | 0/16 | 0/15 | 0/12 | 1/11 | 1/54 |
| GastritisGastrointestinal disorders | 0/16 | 1/15 | 0/12 | 0/11 | 1/54 |
| PneumoniaInfections and infestations | 1/16 | 1/15 | 0/12 | 0/11 | 2/54 |
| Upper respiratory tract infectionInfections and infestations | 0/16 | 1/15 | 0/12 | 0/11 | 1/54 |
| Status epilepticusNervous system disorders | 1/16 | 1/15 | 0/12 | 0/11 | 2/54 |
| Respiratory distressRespiratory, thoracic and mediastinal disorders | 0/16 | 1/15 | 0/12 | 0/11 | 1/54 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/16 | 0/15 | 0/12 | 0/11 | 1/54 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 1/16 | 0/15 | 0/12 | 0/11 | 1/54 |
| IleusGastrointestinal disorders | 1/16 | 0/15 | 0/12 | 0/11 | 1/54 |
| Event | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years | Overall |
|---|---|---|---|---|---|
| PyrexiaGeneral disorders | 9/16 | 3/15 | 0/12 | 3/11 | 15/54 |
| Upper respiratory tract infectionInfections and infestations | 3/16 | 5/15 | 2/12 | 0/11 | 10/54 |
| ConstipationGastrointestinal disorders | 5/16 | 1/15 | 1/12 | 0/11 | 7/54 |
| Ear infectionInfections and infestations | 0/16 | 4/15 | 1/12 | 0/11 | 5/54 |
| Otitis mediaInfections and infestations | 4/16 | 4/15 | 0/12 | 0/11 | 8/54 |
| ConvulsionNervous system disorders | 2/16 | 1/15 | 3/12 | 1/11 | 7/54 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/16 | 2/15 | 0/12 | 0/11 | 6/54 |
| DiarrhoeaGastrointestinal disorders | 3/16 | 3/15 | 0/12 | 0/11 | 6/54 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 2/16 | 3/15 | 1/12 | 0/11 | 6/54 |
| Abdominal painGastrointestinal disorders | 3/16 | 0/15 | 0/12 | 0/11 | 3/54 |
| Age, Continuous(Years) | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years | Total |
|---|---|---|---|---|---|
| Mean | 1.18 ± 0.57 | 4.14 ± 1.23 | 9.98 ± 1.30 | 14.86 ± 1.53 | 6.74 ± 5.35 |
| Sex: Female, Male(Participants) | Pregabalin: 1-23 Months | Pregabalin: 2-6 Years | Pregabalin: 7-11 Years | Pregabalin: 12-16 Years | Total |
|---|---|---|---|---|---|
| Female | 8 | 9 | 5 | 3 | 25 |
| Male | 8 | 6 | 7 | 8 | 29 |
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.