ISRCTN47421449进行中（未招募）3 期
A phase III, multicenter, open-label safety study to evaluate the long-term safety and tolerability of SAGE-718 in participants with Huntington’s disease
Sage Therapeutics (United States)0 个研究点目标入组 300 人开始时间: 2023年10月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 14/08/2024:
- •For all participants:
- •1. Completed 718-CIH-201 (NCT05107128) or 718-CIH-202 (NCT05358821) studies or meet eligibility criteria for the de novo cohort.
- •Inclusion criteria for the de-novo cohort:
- •1. Age 25 - 65 years at the time of screening
- •2. Meet all of the following criteria for HD:
- •2.1. Genetically confirmed disease with cytosine-adenine-guanine (CAG) expansion =40
- •2.2. No features of juvenile HD.
- •2.3. CAG-Age-Product (CAP) score =90, as calculated using the CAP formula: AGE × (CAG – 30)/6.49.
- •3. Either Unified Huntington’s Disease Rating Scale (UHDRS) -Total Functional Capacity (TFC) score=13 and Score = 25 on the Montreal Cognitive Assessment (MoCA) OR UHDRS-TFC =12 and MoCA >25 at screening (Days -28 to -1).
- •4. Completion of Huntington's Disease Cognitive Assessment Battery (HD-CAB) Trail Making-B Test in <240 seconds at Screening (Days -28 to -1)
- •5. Ability to adhere with the study protocol.
- •Previous participant inclusion criteria as of 07/03/2024 to 14/08/2024:
- •For all participants:
- •1. Completed 718-CIH-201 (NCT05107128) or 718-CIH-202 (NCT05358821) studies or meet eligibility criteria for the de novo cohort.
- •Inclusion criteria for the de-novo cohort:
- •1. Age 25 - 65 years at the time of screening
- •2. Meet all the following criteria for HD:
- •2.1. Genetically confirmed disease with cytosine-adenine-guanine (CAG) expansion =40
- •2.2. No features of juvenile HD.
- •2.3. CAG-Age-Product (CAP) score =90, as calculated using the CAP formula: AGE × (CAG – 30)/6.49.
- •3. Either Unified Huntington’s Disease Rating Scale (UHDRS) -Total Functional Capacity (TFC) score=13 or Score > 25 on the Montreal Cognitive Assessment (MoCA) at screening (one or the other; not both).
- •5. Ability to adhere with the study protocol.
- •Previous participant inclusion criteria:
- •For all participants:
- •1. Completed 718-CIH-201 (NCT05107128) or 718-CIH-202 (NCT05358821) studies or meet eligibility criteria for the de novo cohort.
- •Inclusion criteria for the rollover participants:
- •1. No significant decline in functional status since the last visit in 718-CIH-201 or 718-CIH-202, in the opinion of the investigator.
- •Inclusion criteria for the de-novo cohort:
- •1. Age 25 - 65 years at the time of screening
- •2. Meet all the following criteria for HD:
- •- Genetically confirmed disease with cytosine-adenine-guanine (CAG) expansion =40
- •- No features of juvenile HD.
- •3. CAG-Age-Product (CAP) score =90, as calculated using the CAP formula: AGE × (CAG – 30)/6.49.
- •4. Unified Huntington’s Disease Rating Scale (UHDRS) -Total Functional Capacity (TFC) score=13 or Score > 25 on the Montreal Cognitive Assessment (MoCA) at screening.
- •5. Ability to adhere with the study protocol.
排除标准
- •Current participant exclusion criteria as of 14/08/2024:
- •Exclusion criteria for all participants:
- •1. Have a diagnosis of an ongoing neurodegenerative condition other than HD, including but not limited to, Alzheimer’s Disease, vascular dementia, dementia with Lewy bodies, or Parkinson’s Disease.
- •Exclusion criteria specific for the de-novo cohort:
- •1. Have previous exposure to gene therapy study, or have participated in any other HD investigational drug, biologic, or device trial within 180 days or non-HD drug, biologic or device trial within 30 days or 5 half-lives (whichever is longer). Participants with confirmation of enrollment in the placebo arm of these investigational trials would not be excluded. Additionally, participants who have received treatment with antisense oligonucleotides or a messenger ribonucleic acid (mRNA)splicing modifier will be excluded.
- •Exclusion criteria for the rollover participants:
- •1. Have one or more ongoing serious adverse events (SAEs) from the parent study.
- •2. Have ongoing, unresolved AE(s), which in the opinion of the investigator or sponsor, is likely to interfere with study conduct or compliance.
- •Previous participant exclusion criteria:
- •Exclusion criteria for all participants:
- •1. Have a diagnosis of an ongoing neurodegenerative condition other than HD, including but not limited to, Alzheimer’s Disease, vascular dementia, dementia with Lewy bodies, or Parkinson’s Disease.
- •Exclusion criteria specific for the de-novo cohort:
- •1. Have participated in a previous clinical study of SAGE-718, have participated in a previous gene therapy study, or have participated in any other drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer), unless the patient participated solely in the placebo arm of the study. Additionally, participants who have received treatment with antisense oligonucleotides or a messenger ribonucleic acid (mRNA)splicing modifier will be excluded.
- •Exclusion criteria for the rollover participants:
- •1. Have ongoing serious adverse events (SAEs) from the parent study.
- •2. Have ongoing, unresolved AE(s), which in the opinion of the investigator or sponsor, is likely to interfere with study conduct or compliance.
- •Previous participant exclusion criteria as of 07/03/2024 to 14/08/2024:
- •Exclusion criteria for all participants:
- •1. Have a diagnosis of an ongoing neurodegenerative condition other than HD, including but not limited to, Alzheimer’s Disease, vascular dementia, dementia with Lewy bodies, or Parkinson’s Disease.
- •Exclusion criteria specific for the de-novo cohort:
- •1. Have participated in a previous gene therapy study, or have participated in any other HD investigational drug, biologic, or device trial within 180 days or 5 half-lives (whichever is longer). Participants with confirmation of enrollment in the placebo arm of these investigational trials would not be excluded. Additionally, participants who have received treatment with antisense oligonucleotides or a messenger ribonucleic acid (mRNA)splicing modifier will be excluded.
- •Exclusion criteria for the rollover participants:
- •1. Have ongoing serious adverse events (SAEs) from the parent study.
- •2. Have ongoing, unresolved AE(s), which in the opinion of the investigator or sponsor, is likely to interfere with study conduct or compliance.
- •Previous participant exclusion criteria:
- •Exclusion criteria for all participants:
- •1. Have a diagnosis of an ongoing neurodegenerative condition other than HD, inclu
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