EUCTR2010-020852-79-IT进行中（未招募）1 期
A double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of pregabalin as adjunctive therapy in children 4 -16 years of age with partial onset seizures
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- PFIZER INC.
- 入组人数
- 153
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject and/or parent/legally acceptable representative has been informed of all pertinent aspects of the study. When there are two parents or two legally acceptable representatives, consent should be obtained from both of the child’s parents/legal representatives if present at the meeting where the informed consent document is signed. Subject to local regulations whenever the minor is able to give assent, the minor’s assent must also be obtained. 2. Subjects and/or parent(s)/legally acceptable representative who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to complete daily seizure diaries and monitor seizure frequency. 4. Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the Screening Visit. 5. Diagnosis of epilepsy with partial onset seizures classified as simple partial, complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE)3 Diagnosis must be established by: ? Subject’s history (eg, description of seizures excluding confounding disorders such as pseudoseizures, syncopes etc) family history and neurological exam. ? Subjects must have had a contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain and EEG testing within 24 months of the Screening Visit. Results must be consistent with the diagnosis of focal-onset epilepsy and must demonstrate that no abnormality is likely to be progressive. ? Confirmation of diagnosis by independent reviewer before randomization. 6. Must have a partial onset seizure frequency of at least 3 seizures per 28-day period prior to screening. Must have a partial onset seizure frequency of >=6 seizures and no continuous 4 week seizure free period during the 8 week baseline phase prior to randomization. 7. Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening). Benzodiazepine medication used on a regular basis at a stable dosage will be considered 1 of the concurrent antiepileptic treatments. A previously implanted Vagus nerve stimulator (VNS) for the treatment of epilepsy is allowed and will be considered one of the 3 antiepileptic treatments. 8. A 12-lead ECG at screening without significant abnormal findings as determined by the investigator and confirmed by the Central ECG Reader.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 153
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Primary generalized seizures (including in the setting of co existing partial onset seizures) 2. Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome. 3. A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness. Any febrile seizures within 1 year of screening. 4. Status epilepticus within 1 year prior to screening. 5. Seizures related to drugs, alcohol, or acute medical illness. 6. Any change in AED regimen (type of medication or dose) within 28 days of the Screening Visit or during the Baseline Phase. 7. Progressive structural CNS lesion or a progressive encephalopathy. 8. Progressive errors of metabolism. 9. Known or suspected chronic hematologic, hepatic or renal disease 10. Estimated creatinine clearance (ClCR) <80 mL/min/1.73 m2 11. Other severe acute or chronic medical or psychiatric condition (eg, current major depressive disorder; schizophrenia or other psychoses) or laboratory abnormality that may increase the risk associated with study participation or study medication administration or may interfere with the interpretation of the study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 12. Pregnant or nursing females; menarchal females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least 14 days prior to the first dose of study medication until completion of the study. 13. Taking any non antiepileptic (non AED) medication that could alter the effectiveness of the subject’s medication, response, seizure frequency or characteristics. Medications for Attention Deficit/Hyperactivity Disorder will be permitted if medication doses are stable and remain so throughout the duration of study. A ketogenic diet will also be allowed given that the diet is adhered to for the duration of the study. 14. The concomitant use of gabapentin is prohibited. 15. Use of cocaine, phencyclidine (PCP), or other illegal or illicit drugs is prohibited. Use of amphetamines, barbiturates, opiates, or benzodiazepines without a valid current prescription is prohibited. 16. History of lack of efficacy for treatment of epilepsy with pregabalin at presumed efficacious doses. 17. Known allergy or intolerance to pregabalin or other ?2? ligands (eg, gabapentin). 18. Prior participation in a pregabalin clinical trial. 19. Treatment with pregabalin for any reason within 60 days prior to screening. 20. History of sensitivity to heparin or heparin induced thrombocytopenia. 21. Unwilling or unable to comply with the Life Style Guidelines. 22. Not reasonably expected to complete the trial. 23. Participation in other clinical studies within 30 days before the current study begins and/or during study participation. 24. Subjects whose parents/legally acceptable representatives are investigational site staff members or subjects whose parents/legally acceptable representative are Pfizer employees directly involved in the conduct of the trial. 25. Any subjects considered at risk of suicide based on the MINI KID and C SSRS Lifetime (subjects age >=6 years) or CBCL (subjects <6 years) or likely to self harm based on clinical judgment.
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