Open Label Rollover Study of Triumeq in Patients With Amyotrophic Lateral Sclerosis (ALS) Following the Lighthouse II Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 7
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
研究概览
简要总结
Triumeq is an approved medicine for HIV. The effectiveness of Triumeq in Amyotrophic Lateral Sclerosis (ALS) is being investigated in the Lighthouse II trial. This study aims to assess whether Triumeq is safe and effective at delaying ALS disease progression when given long term. It is available for participants who have completed the Lighthouse II study. The main measurements are safety, tolerability and survival.
The study will go for approximately 2 years.
详细描述
Treatment options for ALS are very limited and there is a high unmet need for effective treatments. Triumeq targets a known neuron toxic pathway and is currently under investigation in a double blind placebo controlled trial, Lighthouse II. This study will be open to participants who took part in, and were still taking the study drug when they completed the Lighthouse II trial, in Australia and New Zealand.
The nature of the target and the mechanism of action of Triumeq are well understood. Participation in this rollover study is concurrent with standard of care, so participants are not limited in their use of therapies.
Participants will be assessed for adverse events, discontinuation of study medication, survival, measures of daily functioning, plus biomarker assessments of blood and urine samples.
Participant contacts may be face to face, or remote, and will be at 3 monthly intervals until approx December 2026 by which time it is anticipated the results of the Lighthouse II study will be available.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with ALS according to the Lighthouse II protocol who completed the Lighthouse II trial.
- •Participants taking Riluzole must be on a stable dose.
- •Participants taking taurursodiol supplements (TUDCA) can participate in this trial if the supplement does not contain sodium phenylbutyrate.
- •Women must not become pregnant (e.g., post-menopausal, surgically sterile, using highly effective birth control methods or not having potentially reproductive sex) for the duration of the study plus five days; and women of childbearing potential must have a negative urine pregnancy test at baseline and be non-lactating.
- •For participants taking antacids (regularly or as required), participant is willing and able to avoid taking antacids for at least 6 hours before and 2 hours after the Triumeq dose.
- •Capable of providing informed consent and complying with the trial procedures.
排除标准
- •In the Principal Investigator's opinion, the participant is unlikely to be compliant with the study drug dosing.
- •People who are HLA-B*5701 positive.
- •Presence of HIV antibodies at screening
- •Presence of Hepatitis C antibodies at screening unless participants have had effective treatment for Hepatitis C
- •Presence of Hepatitis B core or surface antigen at screening
- •Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of the excipients.
- •Moderate to severe hepatic impairment, as defined by local clinical guidelines.
- •Participation in any other investigational drug trial or using another investigational drug within 5 half-lives of that drug.
- •Use of NIV ≥22 h per day or having a tracheostomy
- •Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness
- •Taking medication contraindicated with Triumeq: Dofetilide or Fampridine (dalfampridine)
研究组 & 干预措施
Triumeq open label
Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg ('Triumeq') one tablet daily
干预措施: Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq) (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
时间窗: Duration of the study plus 7 days
The primary endpoint of this trial is whether a patient had any drug related (definite, probable, possible) adverse events over the course of the extension trial. Tolerability is defined as the number of participants discontinuing study medication. Adverse events will be described in terms of relationship to temporary or permanent discontinuation of the study medication.
次要结局
未报告次要终点