Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: 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.

Height was recorded in centimeters.

Time frame: Month 12/Early Termination

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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.

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.

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

Population: Safety analysis set: All participants who received at least one dose of study medication were included.