EUCTR2010-021448-17-DE进行中（未招募）不适用
A multicenter, open-label, follow-up study to evaluate the long-term safety and tolerability of BGG492 TID as adjunctive therapy in patients with partial onset seizures completing double-blind, placebo-controlled study CBGG492A2207 or CBGG492A2211.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
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
- •1. Have completed the 10-week Double-blind Treatment Evaluation Phase plus one week of dose-tapering (Visit 9, Day 78) in study CBGG492A2207, have cooperated with the study procedures and have not experienced persistent tolerability issues;
- •2. Patients who wish to continue BGG492 treatment and from whom the investigator believes a reasonable benefit from the long-term
- •administration of BGG492 may be expected;
- •3. Male and female outpatients age 18 to 66 years (inclusive)
- •4. Weight of = 45 Kg (99 lb);
- •5. Are currently treated with a stable dose of one or a maximum of three licensed AEDs and are known to take their medication(s) as directed.
- •5.1 Allowed AEDs: Carbamazepine, Eslicarbazepine, Oxcarbazepine, Phenytoin, Valproate, Lacosamide, Lamotrigine, Levetiracetam, Clobazam, Topiramate, Zonisamide, Gabapentin, Pregabalin, Phenobarbital and Primidone;
- •5.2 Vagal nerve stimulation (VNS) will be counted as one AED;
- •5.3 Stable benzodiazepine treatment administered for e.g. epilepsy, anxiety, or sleep disorders will be counted as one AED.
- •6. Are reliable and willing to make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events;
- •7. Have provided written informed consent before any extension assessment is performed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
- •1. Have completed the 10-week Double-blind Treatment Evaluation Phase plus one week of dose-tapering (Visit 9, Day 78) in study CBGG492A2207, have cooperated with the study procedures and have not experienced persistent tolerability issues;
- •2. Patients who wish to continue BGG492 treatment and from whom the investigator believes a reasonable benefit from the long-term
- •administration of BGG492 may be expected;
- •3. Male and female outpatients age 18 to 66 years (inclusive)
- •4. Weight of = 45 Kg (99 lb);
- •5. Are currently treated with a stable dose of one or a maximum of three licensed AEDs and are known to take their medication(s) as directed.
- •5.1 Allowed AEDs: Carbamazepine, Eslicarbazepine, Oxcarbazepine, Phenytoin, Valproate, Lacosamide, Lamotrigine, Levetiracetam, Clobazam, Topiramate, Zonisamide, Gabapentin, Pregabalin, Phenobarbital and Primidone;
- •5.2 Vagal nerve stimulation (VNS) will be counted as one AED;
- •5.3 Stable benzodiazepine treatment administered for e.g. epilepsy, anxiety, or sleep disorders will be counted as one AED.
- •6. Are reliable and willing to make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events;
- •7. Have provided written informed consent before any extension assessment is performed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of status epilepticus or seizure clusters (where individual seizures cannot be counted according to the judgement of the investigator) occurring during Study CBGG492A2207 or in the period between the end of study
- •CBGG492A2207 and the start of study CBGG492A2212 for patients
- •experiencing a treatment gap;
- •2. Have been treated with:
- •2.1 Felbamate, unless treatment has been continuous for = 2 years;
- •2.2 Vigabatrin during 26 weeks prior to the first dose of open-label
- •medication in the extension study;
- •2.3 Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and
- •narcotic analgesics such as e.g. morphine, oxycodone, fentanyl, codeine within 8 weeks prior to the first dose of open-label medication in the extension study;
- •2.4 L-Dopa formulations;
- •2.5 Used concomitant medication that are potential inhibitors of OATP
- •transporters e.g. cyclosporine, rifampin, fluvastatine, fexofenadine 8 weeks prior to the first dose of open-label medication in the extension study.
- •3. No physical examination changes suggestive of progressive
- •neurological changes (e.g. Alzheimer's disease, Parkinson's Disease,
- •Multiple Sclerosis) during Study CBGG492A2207;
- •4. History of hypersensitivity to the study drug or to drugs of similar
- •chemical classes (e.g. sulfonamides);
- •5. Have had multiple drug allergies or one ore more severe drug reactions to an AED, including dermatological reactions, (e.g. Stevens-Johnson syndrome, hematological, or organ toxicity reactions); a rash would not be exclusionary;
- •6. Use of other investigational drugs apart from BGG492 either at the time of enrollment in the extension study or within 5 half-lives prior to enrollment in the extension study if the experimental medication was taken during the potential treatment gap between the studies;
- •7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a negative hCG laboratory test (= 5 mIU/mL) and a negative urine test prior to administering the first dose of open-label study medication;
- •8. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means:
- •Effective contraception methods include one of the following:
- •Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository),
- •other more effective forms such as oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or total abstinence, or male/female sterilization.
- •For a full list please see protocol section 4.2
- •1. History of status epilepticus or seizure clusters (where individual seizures cannot be counted according to the judgement of the investigator) occurring during Study CBGG492A2207 or in the period between the end of study
- •CBGG492A2207 and the start of study CBGG492A2212 for patients
- •experiencing a treatment gap;
- •2. Have been treated with:
- •2.1 Felbamate, unless treatment has been continuous for = 2 years;
- •2.2 Vigabatrin during 26 weeks prior to the first dose of open-label
- •medication in the extension study;
- •2.3 Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and
- •narcotic analgesics such as e.g. morphine, oxycodone, fentanyl, codeine within 8 weeks prior to the first dose of open-label medication in the extension study;
- •2.4 L-Dopa formulations;
- •2.5 Used concomitant medication that are potential inhibitors of OATP
- •transporters e.g. cyclosporine, rifampin, fluvastatine, fexofenadine 8 weeks prior to the first dose of open-label medication in the extension study.
- •3. No physical examination changes suggestive of progressive
- •neurological changes (e.g. Alzheimer's disease, Parkinson's Disease,
- •Multiple Sclerosis) during Study CBGG492A2207;
- •4. History of hypersensitivity to the study drug or to drugs of similar
- •chemical classes (e.g. sulfonamides);
- •5. Have had multiple drug allergies or one ore more severe drug reactions to an AED, including dermatological reactions, (e.g. Stevens-Johnson syndrome, hematological, or organ toxicity reactions); a rash would not be exclusionary;
- •6. Use of other investigational drugs apart from BGG492 either at the time of enrollment in the extension study or within 5 half-lives prior to enrollment in the extension study if the experimental medication was taken during the potential treatment gap between the studies;
- •7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a negative hCG laboratory test (= 5 mIU/mL) and a negative urine test prior to administering the first dose of open-label study medication;
- •8. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means:
- •Effective contraception methods include one of the following:
- •Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository),
- •other more effective forms such as oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or total abstinence, or male/female sterilization.
- •For a full list please see protocol section 4.2
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