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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00448916
First received: March 15, 2007
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Epilepsies, Partial
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AE). [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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:
  • 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. ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Derived Body Mass Index Data (BMI) at Month 12/Early Termination. [ Time Frame: Month 12/Early Termination ] [ Designated as safety issue: Yes ]
    BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2.

  • 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 ] [ Designated as safety issue: Yes ]
    Weight was recorded in kilograms and weight change from Baseline was reported.

  • Height at Month 12/Early Termination. [ Time Frame: Month 12/Early Termination ] [ Designated as safety issue: Yes ]
    Height was recorded in centimeters.

  • Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months). [ Time Frame: Week 1 to 12 Months ] [ Designated as safety issue: Yes ]

    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.


  • Number of Participants With Hematotolgical Abnormalities. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy). [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Abnormalities in Endocrine Panel (Hormones). [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Abnormalities in Creatine Kinase. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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.

  • Seizure Frequency. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 54
Study Start Date: May 2007
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin
Orally-administered pregabalin
Drug: Pregabalin
Orally-administered pregabalin

  Eligibility

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448916

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
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, United States, 33609
The Office of Sergio J Jacinto, MD
Tampa, Florida, United States, 33603
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
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00448916     History of Changes
Other Study ID Numbers: A0081075, 2010-020731-39
Study First Received: March 15, 2007
Results First Received: October 6, 2014
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015