Trial record 1 of 1 for:
a0081042
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
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| ClinicalTrials.gov Identifier: NCT02072824 |
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Recruitment Status :
Completed
First Posted : February 27, 2014
Results First Posted : October 9, 2018
Last Update Posted : January 20, 2021
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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. )
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Brief Summary:
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Partial Onset Seizures | Drug: Pregabalin Dose Level 1 Drug: Pregabalin Dose Level 2 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 175 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures |
| Actual Study Start Date : | September 16, 2014 |
| Actual Primary Completion Date : | March 13, 2018 |
| Actual Study Completion Date : | March 13, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Seizures
Drug Information available for:
Pregabalin
| Arm | Intervention/treatment |
|---|---|
| Experimental: Study Drug Level 1 |
Drug: Pregabalin Dose Level 1
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase |
| Experimental: Study Drug Level 2 |
Drug: Pregabalin Dose Level 2
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase |
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase |
Primary Outcome Measures :
- Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase [ Time Frame: Day 1 up to Day 14 ]All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).
Secondary Outcome Measures :
- Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase [ Time Frame: Day 1 up to Day 14 ]Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment.
Other Outcome Measures:
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to End of study (EOS) (maximum Day 25) ]An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
- Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to EOS (maximum Day 25) ]Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.
- Number of Adverse Events by Severity [ Time Frame: Day 1 up to EOS (maximum Day 25) ]An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function.
- Number of Participants With Laboratory Test Abnormalities [ Time Frame: From Baseline up to EOS (maximum Day 25) ]Abnormality Criteria: hemoglobin,hematocrit,red blood cells(RBC)count:<0.8*lower limit of normal[LLN],platelets:<0.5*LLN/>1.75*upper limit of normal[ULN]; leukocytes:<0.6*LLN/>1.5*ULN; lymphocytes,neutrophils, total protein,albumin, tetraiodothyronine,thyroid stimulating hormone:<0.8*LLN/>1.2*ULN; basophils,eosinophils,monocytes:>1.2*ULN; prothrombin [PT],PT international ratio:>1.1*ULN; aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,gamma glutamyl transferase:>0.3*ULN; bilirubin:>1.5*ULN; blood urea nitrogen,creatinine, cholesterol,triglycerides:>1.3*ULN; sodium: <0.95*LLN/>1.05*ULN; potassium,chloride,calcium,bicarbonate:<0.9*LLN/>1.1*ULN; glucose fasting:<0.6*LLN/>1.5*ULN; creatine kinase:>2*ULN;urine glucose,ketone,protein:>=1;urine WBC,RBC:>= 20/High Power Field[HPF]; urine casts,hyaline casts:>1/Low Power Field; urine bacteria:>20/HPF.
- Number of Participants With Vital Signs Abnormalities [ Time Frame: From Baseline (BL) up to EOS (maximum Day 25) ]Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: maximum increase and decrease of greater than or equal to (>=) 30 millimeter of mercury (mmHg) from baseline; sitting/supine diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline.
- Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study [ Time Frame: Screening and EOS (maximum Day 25) ]Physical examinations evaluated the following body systems/organs: abdomen; ears; extremities; eyes; general appearance; head; heart; lungs; lymph nodes; mouth; musculoskeletal; nose; skin and throat. Abnormalities in physical examination were based on investigator's discretion.
- Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study [ Time Frame: Baseline (BL) and EOS (maximum Day 25) ]Neurological examinations included: coordination; cranial nerve function (CNF); gait and station; level of consciousness (LOC); lower and upper extremity sensation; muscle strength; muscle tone; nystagmus; reflexes and speech. Abnormalities in neurological examination were based on investigator's discretion and also, some components of the neurological examination were not done for certain participants due to participant age or significant developmental impairment. Only those categories of neurological examination in which at least 10% of participants had an abnormality in any treatment group at any time point were reported in this outcome measure.
- Number of Participants With Electrocardiogram (ECG) Abnormalities [ Time Frame: From screening up to EOS (maximum Day 25) ]Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal (maximum QTCB interval 450-<480 msec), were reported in this outcome measure.
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| Ages Eligible for Study: | 1 Month to 3 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject must have 3 partial onset seizures in the month prior to screening.
- Subject must have 2 partial onset seizures during the 48 hour baseline phase.
- Signed Informed Consent.
- On 1-3 stable anti-epileptic drugs at screening.
Exclusion Criteria:
- Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
- Lennox-Gasteau, BECTS, and Dravet's syndrome.
- Status epliepticus within 1 year of screening.
- Any change in AED regimen with 7 days of screening.
- Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
- Progressive errors of metabolism.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072824
Locations
Show 72 study locations
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study Documents (Full-Text)
Documents provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Documents provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Statistical Analysis Plan [PDF] April 6, 2018
Study Protocol [PDF] December 15, 2017
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| ClinicalTrials.gov Identifier: | NCT02072824 |
| Other Study ID Numbers: |
A0081042 2013-003420-37 ( EudraCT Number ) |
| First Posted: | February 27, 2014 Key Record Dates |
| Results First Posted: | October 9, 2018 |
| Last Update Posted: | January 20, 2021 |
| Last Verified: | September 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
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Partial Onset Seizures Epilepsy Safety Efficacy Tolerability Pregabalin |
Lyrica Adjunctive treatment Placebo controlled blinded Eligibility Criteria |
Additional relevant MeSH terms:
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Seizures Neurologic Manifestations Nervous System Diseases 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 |