A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 主要终点
- Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).
详细描述
Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections
- •Willing and able to return for scheduled clinic visits and study assessments
- •Noncustodial, stable address and phone
- •Written, informed consent
排除标准
- •Pregnancy or lactation
- •Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)
研究组 & 干预措施
Medisorb naltrexone 380 mg
干预措施: Medisorb naltrexone 380 mg (Drug)
Medisorb naltrexone 190 mg
干预措施: Medisorb naltrexone 190 mg (Drug)
结局指标
主要结局
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
时间窗: Up to 3.5 years of monthly treatment
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period).
次要结局
未报告次要终点