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

• ClinicalTrials.gov Identifier: NCT00448916
• Recruitment Status: Completed
• First Posted: March 19, 2007
• Results First Posted: December 2, 2014
• Last Update Posted: January 25, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Epilepsies, Partial	Drug: Pregabalin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 12-month Open-label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Pregabalin In Pediatric Patients With Partial Onset Seizures
• Study Start Date: May 2007
• Actual Primary Completion Date: October 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pregabalin; Orally-administered pregabalin	Drug: Pregabalin; Orally-administered pregabalin

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Events (AE). [ Time Frame: 12 Months ]
   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.

Secondary Outcome Measures :

1. 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. [ Time Frame: 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.
2. 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. [ Time Frame: 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.
3. Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months). [ Time Frame: 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.
4. Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months). [ Time Frame: 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.
5. Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months). [ Time Frame: 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.
6. Derived Body Mass Index Data (BMI) at Month 12/Early Termination. [ Time Frame: Month 12/Early Termination ]
   BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2.
7. 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. [ Time Frame: Baseline, 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.
8. Height at Month 12/Early Termination. [ Time Frame: Month 12/Early Termination ]
   Height was recorded in centimeters.
9. Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months). [ Time Frame: 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.

10. Number of Participants With Hematotolgical Abnormalities. [ Time Frame: 12 Months ]
    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.
11. Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy). [ Time Frame: 12 Months ]
    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. Number of Participants With Abnormalities in Endocrine Panel (Hormones). [ Time Frame: 12 Months ]
    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.
13. Number of Participants With Abnormalities in Creatine Kinase. [ Time Frame: 12 Months ]
    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.
14. Seizure Frequency. [ Time Frame: 28 Days ]
    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.
15. Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein). [ Time Frame: 12 Months ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

University of South Alabama

Mobile, Alabama, United States, 36604

University of South Alabama Department of Neurology

Mobile, Alabama, United States, 36693

United States, Arizona

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

United States, Arkansas

The Children's Clinica of Jonesboro, P.A

Jonesboro, Arkansas, United States, 72401

Clinical Study Centers, L. L. C.

Little Rock, Arkansas, United States, 72205

United States, California

UCSF Neurology Clinic

San Francisco, California, United States, 94143

United States, Florida

Child Neurology Center of Northwest Florida

Gulf Breeze, Florida, United States, 32561

The Office of Sergio J Jacinto, MD

Tampa, Florida, United States, 33603

Pediatric Epilepsy & Neurology Specialists

Tampa, Florida, United States, 33609

United States, Missouri

St. John's Clinic

Springfield, Missouri, United States, 65804

St. John's Hospital

Springfield, Missouri, United States, 65804

United States, New York

Women and Children's Hospital of Buffalo

Buffalo, New York, United States, 14222

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

United States, Texas

Baylor College of Medicine - Texas Children's Hospital

Houston, Texas, United States, 77030

Texas Children's Hospital

Houston, Texas, United States, 77030

Road Runner Research, Ltd.

San Antonio, Texas, United States, 78258

Korea, Republic of

Yonsei University College of Medicine Severance Hospital / Department of Pediatric Neurology

Seoul, Korea, Republic of, 120-752

Mexico

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico, 44280

Sponsors and Collaborators

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

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00448916
• Other Study ID Numbers: A0081075; 2010-020731-39 ( EudraCT Number )
• First Posted: March 19, 2007
• Results First Posted: December 2, 2014
• Last Update Posted: January 25, 2021
• Last Verified: November 2014

Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):

Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability

Additional relevant MeSH terms:

Epilepsy; Seizures; Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Pregabalin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs