EUCTR2018-002633-38-IT进行中（未招募）1 期
An open label phase I/IIa trial repurposing carbamazepine (CBZ) for the treatment of skeletal dysplasia in children. - MCDS-Therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Participants where a pathogenic mutation in the gene encoding the COL10A1 protein has been identified by sequence analysis
- •Ambulant at the time of consent/assent, with open epiphyses
- •Willing and able to attend for safety monitoring assessments
- •Willing and able to adhere to the trial visit schedule and other protocol requirements
- •Capable of giving informed consent, or if appropriate, have an acceptable individual capable of giving consent on the participant’s behalf (e.g. parent or legal guardian of a child under 16 years of age)
- •Written informed consent signed by parent(s)/legal guardian(s) and/or the subject, according to the local regulations
- •If female and of childbearing potential, the participant must have a negative pregnancy test [urine beta-human chorionic gonadotropin (ß-hCG)] at baseline and agree to regular pregnancy testing throughout the trial
- •Sexually active female particpants of childbearing potential must practice true abstinence in line with their preferred and usual lifestyle, or use two acceptable effective methods of contraception: a barrier method such as a condom or occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository and an established non-barrier method such as oral, injected, or implanted hormonal methods (hormonal preparations must contain not less than 50µg oestrogen). Use of some alternative non-hormonal method of contraception should be considered: an intrauterine device or intrauterine system for the entire duration of the treatment period
- •Are the trial subjects under 18? yes
- •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 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have reached skeletal maturity
- •Patients who have a planned surgery or planned osteotomy (which in the opinion of the Chief Investigator, Principal Investigator and/or the clinical members of the TMG deems the patient unsuitable for the trial)**Patients who have had a prior adverse reaction to carbamazepine or similar drugs such as oxcarbazepine, or to any related tricyclic antidepressants.
- •Patients known to have atrioventricular block
- •Patients who have a history of bone marrow suppression/depression
- •Patients who have evidence of chronic hepatic or renal impairment
- •Patients who have acute intermittent porphyria
- •Patients who have received a monoamine oxidase inhibitor within 14 days of commencing therapy
- •Patients who have abnormal blood screening results at the time of treatment initiation will be excluded unless the Investigator believes the abnormality to be non-significant clinically
- •Patients of Han Chinese, Thai and other Asian origins who carry the HLA-B*1502 allele
研究者
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