NCT02082249已完成3 期
An Open-Label Three-Part Extension Study Assessing Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications
AbbVie7 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2014年3月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in subjects with advanced Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects completing 12 weeks treatment in Study M12-921 who would benefit from long-term treatment from ABT-SLV
- •Alternatively, subjects who (i) participated in the Phase 2 Study M12-925 (ii) would, in the opinion of the Investigator, benefit from ABT-SLV187 treatment in the Study M12-923, (iii) did not discontinue the M12-925 Study due to safety reason, and (iv) meet all entry requirements. Lastly, subjects who completed another ABT-SLV187 study (e.g., Study M12-927) in South Korea.
- •The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
- •The subject must be willing to continue on treatment.
排除标准
- •Subject is enrolled in another clinical trial.
- •Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
- •Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant and in the opinion of the PI, would be a contraindication to continued levodopa therapy.
- •Uncooperative attitude or reasonable likelihood for non-compliance with the protocol.
- •Subject has current significant suicidal ideation as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale completed at the Week 12 Visit of Study M12-921 or at the Baseline Visit of the current study for M12-925 or M12-927 study subjects.
- •Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-SLV187.
研究组 & 干预措施
ABT-SLV187
Experimental
up to 6 years
干预措施: ABT-SLV187 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: From Day 1 up to 6 years (estimated maximum)
All negative changes in health during the study will be treated and recorded during the study.
次要结局
- Change in Patient Global Impression of Change (PGIC) scores(From Screening Visit 2 of M12-921 to Week 52 of M12-923)
- Change in the mean daily "Off" time (hours) as measured by the Parkinson's Disease (PD) Diary ©(From Day 1 to Week 52)
- Change in Clinical Global Impression of Change (CGI-C) scores(From Screening Visit 2 of M12-921 to Week 52 of M12-923)
- Change in the Unified Parkinson's Disease Rating Scale (UPDRS) score(From Day 1 up to 36 months (estimated maximum))
- Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) scores(From Screening Visit 2 of M12-921 to Week 52)
- Change in PD Diary mean daily "On" time without troublesome dyskinesia ("On" time without dyskinesia or with non-troublesome dyskinesia) or "On" time with troublesome dyskinesia(From Day 1 to Week 52)
研究者
研究点 (7)
Loading locations...
相似试验
撤回
3 期
Extension Study in Primary Distal Renal Tubular AcidosisAcidosis, Renal TubularNCT03831152Advicenne Pharma
招募中
3 期
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without InhibitorsHemophilia AHemophilia BNCT05145127Pfizer245
已完成
3 期
A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed DyslipidemiaMixed DyslipidemiaNCT00491530Abbott310
终止
2 期
A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 TrialsAtopic DermatitisNCT05439941Evelo Biosciences, Inc.287
终止
3 期
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)Primary Immune ThrombocytopeniaNCT04596995UCB Biopharma SRL43