Partial Onset Seizures Clinical Trial
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
Verified date | September 2018 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 175 |
Est. completion date | March 13, 2018 |
Est. primary completion date | March 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 3 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belarus | GU Republican Scientific and Practical Center Mother and Child | Minsk | |
Belgium | UZ Brussel | Brussels | Bruxelles Capitale |
Bosnia and Herzegovina | University Clinical Centre of the Republic of Srpska | Banja Luka | |
Bulgaria | UMHAT Dr. Georgi Stranski Ltd. | Pleven | |
Bulgaria | UMHAT "Sveti Georgi" Ltd. | Plovdiv | |
China | Beijing Children's Hospital | Beijing | |
China | The First Bethune Hospital of Jilin University | Changchun | Jilin |
China | Children's Hospital of Fudan University | Shanghai | Shanghai |
France | Hopital Raymond Poincare | Garches | |
Germany | Universitaetsklinikum Jena | Jena | Thueringen |
Greece | University General Hospital Attikon | Athens | |
Greece | General Hospital of Thessaloniki Ippokratio | Thessaloniki | |
Hungary | Dr. Kenessey Albert Korhaz es Rendelointezet | Balassagyarmat | |
Hungary | Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia | Budapest | |
Hungary | Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika | Budapest | |
Hungary | Szent János Kórház es Észak Budai Egyesitett Kórházak | Budapest | |
Hungary | Szent Margit Kórház | Budapest | |
Hungary | Debreceni Egyetem Klinikai Központ | Debrecen | |
Israel | Pharmacy of The E. Wolfson Medical Center | Holon | |
Israel | The E. Wolfson Medical Center | Holon | |
Israel | Pharmacy of Tel Aviv Sourasky Medical Center | Tel Aviv | |
Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Lebanon | American University of Beirut Medical Center | Beirut | |
Lebanon | Saint George Hospital - University Medical Center | Beirut | |
Malaysia | Hospital Raja Perempuan Zainab II | Kota Bharu | Kelantan |
Philippines | Cebu Doctors' University Hospital | Cebu City | Cebu |
Philippines | Perpetual Succour Hospital | Cebu City | Cebu |
Philippines | Manila Doctors Hospital | Manila | |
Philippines | Metropolitan Medical Center | Manila | |
Philippines | University of Santo Tomas Hospital | Manila | |
Philippines | Philippine Children's Medical Center | Quezon City | |
Philippines | St. Luke's Medical Center | Quezon City | |
Romania | Centrul Medical Unirea | Bucuresti | |
Romania | Spitalul Clinic de Urgente pentru Copii "Sf. Maria" | Iasi | |
Russian Federation | FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia | Moscow | |
Russian Federation | FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia | Moscow | |
Russian Federation | Nizhmedklinika | Nizhniy Novgorod | Nizhegorodskaya Oblast |
Russian Federation | Perm State Medical University n. a. acad. E.A. Vagner | Perm | Permskiy KRAY |
Russian Federation | Perm State Medical University n. a. acad. E.A. Vagner | Perm | |
Russian Federation | "Baltiyskaya Medicyna" LLC | Saint Petersburg | |
Russian Federation | St. Petersburg State Pediatric Medical University | Saint Petersburg | |
Russian Federation | LLC Medical Technologies | Saint-Petersburg | |
Russian Federation | LLC Medical Technologies | Saint-Petersburg | |
Russian Federation | RSBHI Smolensk Regional Clinical Hospital | Smolensk | |
Russian Federation | SHI Central Clinical Medical Unit | Ulyanovsk | |
Russian Federation | SHI Central Clinical Medical Unit | Ulyanovsk | |
Russian Federation | SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev | Ulyanovsk | |
Russian Federation | MAI Children's City Clinical Hospital 9 | Yekaterinburg | |
Serbia | Mother and Child Healthcare Institute Dr Vukan Cupic | Belgrade | |
Serbia | University Children's Hospital Belgrade | Belgrade | |
Serbia | Institute for Child and Youth Healthcare of Vojvodina | Novi Sad | Vojvodina |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
Taiwan | Chang Gung Memorial Hospital- Kaohsiung branch | Kaohsiung | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | National Taiwan University Hospital | Taipei | |
Thailand | Siriraj Hospital, Faculty of Medicine, Mahidol University | Bangkoknoi | Bangkok |
Thailand | Phramongkutklao Hospital | Ratchathevee | Bangkok |
Turkey | Eskisehir Osmangazi Universitesi Tip Fakultesi | Eskisehir | |
Turkey | Izmir Tepecik Training and Research Hospital | Izmir | Konak |
Turkey | Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi | Trabzon | |
Ukraine | Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5" | Dnipro | |
Ukraine | Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia" | Dnipro | |
Ukraine | Ivano-Frankivska oblasna dytiacha klinichna likarnia | Ivano-Frankivsk | |
Ukraine | DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam | Kyiv | |
Ukraine | Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2 | Uzhgorod | |
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
United States | Pediatric Epilepsy Center of Central Florida | Orlando | Florida |
United States | Pediatric Neurology, PA | Orlando | Florida |
United States | Road Runner Research, Ltd. | San Antonio | Texas |
United States | Pediatric Epilepsy & Neurology Specialists, PA | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, China, France, Germany, Greece, Hungary, Israel, Korea, Republic of, Lebanon, Malaysia, Philippines, Romania, Russian Federation, Serbia, Spain, Taiwan, Thailand, Turkey, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Day 1 up to End of study (EOS) (maximum Day 25) | |
Other | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Day 1 up to EOS (maximum Day 25) | |
Other | Number of Adverse Events by Severity | 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. | Day 1 up to EOS (maximum Day 25) | |
Other | Number of Participants With Laboratory Test Abnormalities | 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. | From Baseline up to EOS (maximum Day 25) | |
Other | Number of Participants With Vital Signs Abnormalities | 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. | From Baseline (BL) up to EOS (maximum Day 25) | |
Other | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | 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. | Screening and EOS (maximum Day 25) | |
Other | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | 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. | Baseline (BL) and EOS (maximum Day 25) | |
Other | Number of Participants With Electrocardiogram (ECG) Abnormalities | 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. | From screening up to EOS (maximum Day 25) | |
Primary | Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | 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). | Day 1 up to Day 14 | |
Secondary | 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 | 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. | Day 1 up to Day 14 |
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