NL-OMON39878已完成3 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 - A0081041 - Pregabalin study for children age 4-16
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
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.
排除标准
- •1. Primary generalized seizures (including in the setting of co-existing partial onset
- •seizures) which include for example:
- •- Clonic, tonic and clonic-tonic seizures (note that partial onset seizures that become secondarily generalized are not exclusionary).
- •- Absence seizures.
- •- Infantile spasms.
- •- Myoclonic, myoclonic atonic, myoclonic tonic 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 (AST and ALT above 3 times the upper limit of normal (ULN); or bilirubin, BUN, or creatinine above 2 times the ULN within the previous 6 months prior to screening). 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 (females who are menarchal must have a negative pregnancy test); 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
研究者
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