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

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsies, Partial
• Intervention / Treatment: Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University College of Medicine Severance Hospital / Department of Pediatric Neurology
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • University of South Alabama
    • Mobile, Alabama, United States, 36693
      • University of South Alabama Department of Neurology
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinica of Jonesboro, P.A
    • Little Rock, Arkansas, United States, 72205
      • Clinical Study Centers, L. L. C.
  • California
    • San Francisco, California, United States, 94143
      • UCSF Neurology Clinic
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Child Neurology Center of Northwest Florida
    • Tampa, Florida, United States, 33609
      • Pediatric Epilepsy & Neurology Specialists
    • Tampa, Florida, United States, 33603
      • The Office of Sergio J Jacinto, MD
  • Missouri
    • Springfield, Missouri, United States, 65804
      • St. John's Hospital
    • Springfield, Missouri, United States, 65804
      • St. John's Clinic
  • New York
    • Buffalo, New York, United States, 14222
      • Women and Children's Hospital of Buffalo
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - Texas Children's Hospital
    • San Antonio, Texas, United States, 78258
      • Road Runner Research, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregabalin; Orally-administered pregabalin	Drug: Pregabalin; Orally-administered pregabalin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 15, 2007
• First Submitted That Met QC Criteria: March 15, 2007
• First Posted (Estimate): March 19, 2007

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsies, Partial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081075; 2010-020731-39 (EudraCT Number)