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

Study Overview
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Brief Summary
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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.

Official Title
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A 12-month Open-label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Pregabalin In Pediatric Patients With Partial Onset Seizures

Conditions
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Epilepsies, Partial

Intervention / Treatment
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* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Partial onset seizures, incompletely controlled on 1-3 medications At least 1 seizure per 28 days, on average Completion of study A0081074 Exclusion Criteria: Primary generalized seizures Progressive CNS pathology Failure to tolerate pregabalin in study A0081074

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin<br>Orally-administered pregabalin | Drug: Pregabalin<br>* Orally-administered pregabalin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability