2023-508407-20-00招募中3 期
A Follow-Up Shiftability Study of Arbaclofen with an Open-Label Extension for the study of Biomarkers for Treatment for Social Function in Children and Adolescents with Autism Spectrum Disorders
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon5 个研究点 分布在 2 个国家目标入组 105 人开始时间: 2024年9月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 5
- 主要终点
- Latency of N170 change at week 14
研究概览
简要总结
To predict long term response to arbaclofen based on a single dose response during the placebo-controlled randomized single dose double blind stage.
研究设计
- 分配方式
- Randomized
- 主要目的
- Shiftability study of arbaclofen with an open-label extension for autism
- 盲法
- Double (Investigator, Analyst, Carer, Subject, Monitor)
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed Written Informed Consent a. Participants or their legal representative must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care. Participants who do not have the capacity to consent will give developmentally appropriate assent. Participants who become adults (18 years of age) during the trial will sign a specific consent during the first visit when they are
- •b. Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing. c. The participant’s parent/caregiver/LAR must be able to speak and understand the local language where the study is conducted sufficiently to understand the nature of the study and to allow for the completion of all study assessments. The same parent/caregiver/LAR must be capable of providing reliable information about the participant’s condition, agree to oversee the administration of study drug, and accompany the participant to all clinic visits. d. Patient must be able to speak and understand the local language where the study is conducted sufficiently to understand the nature of the study and to allow for the completion of all study assessments.
- •Type of Participant and Target Disease Characteristics a. Diagnosis of an Autism Spectrum Disorder according to the DSM-5 criteria b. Participation in the AIMS-2 CT1 (ages at recruitment 5 to 17). Since this study is aimed to start in early 2024, participants will be between 2 to 5 years older. c. Current pharmacological treatment regimen affecting behaviour has been stable for at least 6 weeks prior to screening and is expected to be stable during the duration of the study. d. Current psychotherapeutic/psychosocial interventions affecting behaviour stable for 3 months prior to screening and expected to be stable during the duration of the study (standard regular school breaks and/or annual teacher/classroom change do not qualify for intervention change). e. Participants with a history of seizure disorder must currently be receiving stable treatment with anticonvulsant medication and must have been seizure free for 6 months prior to screening or must be seizure free for 3 years prior to screening if not currently on a stable (>3 months) dose of antiepileptics.
- •Age, Residential and Reproductive Status a. Male or female participants 7 to 23 years of age at the time of providing consent, inclusive. b. Reside or regular contact (at least twice a week) with the parent/carer who is interviewed for the study. c. Negative pregnancy test for females of childbearing potential (participant has experienced onset of menses) d. Females of childbearing potential who are sexually active must agree to use a highly effective form of contraception (i.e., existing surgical sterilization, complete or abstinence or a combination of two affective forms of contraception, such as, for example, condoms plus hormonal treatment). Please, refer to Appendix 4 for a complete list of acceptable contraception methods. e. Male participants with female partners of childbearing potential are eligible to participate if they agree to the conditions stated in section 8.2.1.
排除标准
- •Medical Conditions a. Participants with any condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. This includes, but is not limited to impairment of renal function, evidence or history of malignancy or any significant haematological, endocrine, respiratory, hepatic, cardiovascular or gastrointestinal disease, including any clinically significant abnormalities on ECG. In general, any co-morbid conditions that may interact with study procedures. b. Participants previously excluded from AIMS-2 CT1 due to adverse events.
- •Prior/Concomitant Therapy a. Participants who are currently receiving treatment with racemic baclofen, vigabatrin, tiagabine, or riluzole or other GABA-related medications (e.g. gabapentin or pregabalin) other than arbaclofen in the context of AIMS-2 CT
- •Only occasional benzodiazepine (or derivative drugs) use (PM, i.e. at night) will be allowed. However, participants will be asked to abstain from it, if possible, the night before the recording of the EEG (i.e. visits 1, 2 and 7). b. Participants who are currently receiving pharmacologic treatment affecting behaviour (see concomitant medication section) need to have a stable dose during the 6 weeks prior to the screening visit and for the duration of the study. c. Participating in programs including non-pharmacologic educational, behavioural, and/or dietary interventions affecting behaviour, participation in these programs must have been continuous during the 3 months prior to screening and participants or their parent/caregiver/LAR may not electively initiate new or modify ongoing interventions for the duration of the study. Typical school vacations are not considered modifications of stable programming. d. Participants who have taken another investigational drug within the last 30 days.
- •Physical and Laboratory Test Findings a. Participants with evidence of any significant haematological, endocrine, cardiovascular (including uncorrected symptomatic congenital heart disease), respiratory, renal, hepatic, or gastrointestinal disease, not including mild common paediatric diseases in these areas that are stable (e.g. mild asthma, constipation, etc.), as judged by the investigator.
- •Study-medication related a. Participants who are not able to take oral medications. b. Participants who have a history of hypersensitivity to racemic baclofen. c. Participants with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption should not take this medicine. d. Active peptic ulceration as Baclofen stimulates gastric acid secretion. e. Porphyria.
- •Other exclusion criteria a. Participants who are currently engaged in illicit drug use or alcohol abuse, according to DSM-5 criteria. b. Participants who have previously participated in a clinical trial with arbaclofen (other than our AIMS-2-CT1). c. Women who are breastfeeding.
结局指标
主要结局
Latency of N170 change at week 14
Latency of N170 change at week 14
次要结局
- Latency of N170 change between treatment arms.
研究者
María de la Cruz
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
研究点 (5)
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