DRKS00023837招募中2 期
Open label extension study for monitoring long-term safety in patients with Myoclonic Astatic Epilepsy (Doose-Syndrome) receiving Fenfluramine as add-on therapy - FFA-MAE extension study
niversitätsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin II, Abteilung für Neuropädiatrie und Sozialpädiatrie0 个研究点目标入组 10 人开始时间: 2022年5月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 1 Years 至 17 Years（—）
- 性别
- All
入选标准
- •1. Subjects is currently enrolled in FFA-MAE-study
- •2. Subject and parents/caregiver have been informed of the nature of the study and written informed consent has been obtained from the patient and the legally responsible parents/caregiver.
- •3. Subject is male or non-pregnant, non-lactating female.
- •4. Subject is between 1 (12 months) and 17 years.
- •5. In the medical opinion of the Investigator, subject must be a candidate for continued treatment for an extended period of time with ZX008 (i.e. subject has demonstrated a clinically meaningful benefit with ZX008 in the prior trial, and benefits of continued treatment outweigh potential risks).
- •6. Clinically meaningful benefit is defined as follows: >= 50% reduction of total number of seizures (sum of GTKA, TS, AS, AB, MS) compared to baseline in FFA-MAE-study
- •7. Subjects receives >= 1 AED in addition to ZX008.
- •8. Subjects who are sexually active must use 2 approved methods of highly effective contraception from the time of informed consent until the last dose of study medication.
- •Alternatively, true abstinence is acceptable when it is in line with the subject’s preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, they, with their partner, must comply with the contraceptive requirements detailed above.
排除标准
- •Subject has a known hypersensitivity to Fenfluramine hydrochloride or other components in the study formulation
- •Weight loss of 10 percent or more compared to visit 2 (first intake of IMP) of the FFA-MAE study.
- •Intake of additional medications (including dietary plans) according to Prohibited Food & Medication Section and Appendix 1 in the protocol
- •If medical necessity requires short-term use of one or more of these medications during the course of the study, the investigator will be required to provide approval.
- •Intake of any investigational medicinal product (IMP) other than ZX008.
研究者
相似试验
招募中
2 期
Open label extension study for monitoring long-term safety in patients with Myoclonic Astatic Epilepsy (Doose-Syndrome) receiving Fenfluramine as add-on therapy2024-518520-77-00Universitaetsklinikum Schleswig-Holstein AöR, Universitaetsklinikum Schleswig-Holstein AöR10
已完成
3 期
An open label extension study to evaluate long term use of a Food for Special Medical Purposes (FSMP) in patients with mild Alzheimer*s disease who completed the Souvenir II studyAlzheimerAlzheimers Disease10029305NL-OMON36704Danone Research - Centre for Specialised Nutrition120
进行中（未招募）
1 期
ong-Term Safety Evaluation of dupilumab in patients with asthmaMedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2013-003856-19-ESSanofi-aventis recherche et développement560
招募中
3 期
An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients with Psoriatic ArthritisPsoriatic ArthritisJPRN-jRCT2031220622Oshima Satoe35
招募中
1 期
An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients with Psoriatic Arthritis.Psoriatic ArthritisCTIS2022-501480-41-00Sun Pharmaceutical Industries Limited759