ACTRN12621000370808尚未招募未知
An open label, observational study to investigate the tolerance and response to two low dose medicinal cannabis products with different THC:CBD ratios in Autism Spectrum Disorder (ASD) patients
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6 Years 至 o limit（—）
- 性别
- All
入选标准
- •a.Signed consent (patients and/or carer)
- •b.Have a documented history of Autism Spectrum Disorder (including diagnosis and severity of ASD)
- •c.Patient and caregiver must be able to return to clinic on days specified in the protocol
- •d.Patient and caregiver must be able to adhere to all assessments as described
- •e.Have a valid assessment of severity using the Connors Parent and School assessment or similar tool within the previous 12 months
- •f.Have exhausted conventional therapies listed on the ARTG for ASD
- •g.For paediatric patients only: Have trialled or are being considered for treatment with antipsychotic medications
- •h.For paediatric patients only: Have a letter of support or referral from their treating paediatrician to trial cannabinoid therapies or be managed by Emerald Clinics.
- •i.Planned to be administered either HOPETM 1 and/or HOPETM 2 medicinal cannabis
排除标准
- •j.Patient is currently using recreational or medicinal cannabis, or synthetic cannabinoid-based medications within one month prior to study entry and is unwilling to abstain for the duration of the trial.
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