In short
Clinical trials are studying Ampreloxetine in people with multiple system atrophy and symptomatic neurogenic orthostatic hypotension. These studies aim to evaluate how well it works and how long the benefit lasts, compared with placebo and an active comparator. The main focus is on symptom improvement and patient-reported outcomes.
Key points
- Ampreloxetine is being studied in a Phase 3 clinical trial for people with multiple system atrophy who have symptomatic neurogenic orthostatic hypotension. The study looks at whether the treatment improves symptoms and whether the benefit lasts over time. It compares Ampreloxetine with placebo during a double-blind randomized withdrawal period after an open-label period. The main measurement is the change in OHSA composite score at Week 8. The trial is authorised and plans to enroll 108 participants.
Trial overview
The available trial is a Phase 3 study of Ampreloxetine in people with multiple system atrophy and symptomatic neurogenic orthostatic hypotension (nOH). It is an interventional study, which means participants receive study treatment so researchers can compare results between groups.
The study is authorised and plans to enroll 108 participants. Its brief summary says the goal is to evaluate the efficacy and durability of Ampreloxetine compared with placebo over an open-label period followed by a double-blind randomized withdrawal period.
Who the trial is for
This trial targets participants with MSA, a disease that affects the nervous system, and who also have symptomatic nOH. The data provided here do not list all eligibility rules, but the main population is clear from the study title and summary.
Symptomatic nOH means the blood pressure drop when standing is causing symptoms, such as feeling faint or dizzy. The study is therefore focused on people whose day-to-day life is affected by this blood pressure problem.
How the study is designed
The study includes a 12-week open-label period followed by an 8-week double-blind randomized withdrawal period. In an open-label period, everyone knows which treatment is being given. In a double-blind period, neither the participant nor the researchers know who is receiving which treatment, which helps make the comparison fair.
The trial also compares Ampreloxetine with placebo, and the intervention list includes an active comparator, Gutron® Tabletten 2.5 mg, shown in the source data. A placebo is a look-alike treatment without the active study drug, while an active comparator is another treatment used for comparison.
What the trial measures
The main endpoint is the change in the OHSA composite score at Week 8 during the double-blind randomized withdrawal period. An endpoint is the main result researchers use to judge whether a treatment works.
OHSA is a symptom score for orthostatic hypotension, so this outcome reflects how the participant feels and functions, not only a blood pressure reading. The brief summary also states that the study is looking at both efficacy and durability, meaning how well the treatment works and how long the effect lasts.
Key study details
The trial ID is NCT05696717. The study phase is Phase 3 and the status is Authorised.
The intervention list in the source includes Ampreloxetine tablets, oral Ampreloxetine 10 mg, and Gutron® Tabletten 2.5 mg as the comparator treatment. The source does not provide more details on dosing schedules beyond what is listed in the trial record.