Table of contents
- Trial overview
- Pulmonary arterial hypertension study
- Migraine study
- Key endpoints and what they mean
- Who can participate
- Study design and phase
Trial overview
Two clinical trials are listed for Alpha-Tocopherol, and they focus on different diseases and patient groups.[1][2] One trial is in people with pulmonary arterial hypertension, and the other is in women with migraine related to menstruation or perimenopause.[1][2]
Pulmonary arterial hypertension study
The first trial is the REVIDAH study, which is a Phase 3 interventional trial in patients with pulmonary arterial hypertension.[1] The trial is authorised and plans to enroll 102 participants.[1]
This study includes patients with pulmonary arterial hypertension of the following types according to the 2022 ERS/ESC guidelines: idiopathic, hereditary, drug- and toxin-induced PAH, or PAH associated with connective tissue disease.[1] In simple terms, this means the study is limited to specific forms of high blood pressure in the lungs.[1]
The brief summary says the study is testing whether a vitamin D supplement regimen with calcifediol can lead to clinical improvement without clinical worsening at week 24 compared with placebo.[1] Alpha-Tocopherol is listed among the oral interventions in the trial record.[1]
Migraine study
The second trial is an open-label randomized controlled trial called WHAT!, and it studies migraine.[2] It is authorised and plans to enroll 360 participants.[2]
This study includes women with menstrually-related migraine, pure menstrual migraine, or perimenopausal migraine.[2] The study compares continuous daily use of ethinylestradiol/levonorgestrel with vitamin E 400 IU/day, and the record lists a vitamin E complex as one of the oral interventions.[2] Alpha-Tocopherol is the substance named in the trial data for this article.[2]
The main goal is to measure the mean change from baseline in mean monthly migraine days during a 28-day period at the 12-week timepoint.[2] This tells researchers whether the treatment changes how often migraines happen over time.[2]
Key endpoints and what they mean
A primary outcome is the main result a trial wants to measure.[1][2] In the PAH study, the main outcome is clinical improvement with no clinical worsening at week 24.[1]
The PAH study defines clinical improvement as a change in at least two areas: walking distance, risk score, BNP or NT-proBNP blood levels, or TAPSE/SPAP ratio.[1] Clinical worsening means serious disease progression events such as hospitalization, treatment escalation, symptom progression, transplant, atrial septostomy, or PAH-related death.[1]
In the migraine study, the primary endpoint is the change in average monthly migraine days over a 28-day period at weeks 9 to 12.[2] This is a direct way to see whether the study treatment changes migraine frequency.[2]
Who can participate
The PAH trial is for patients who already have a diagnosis of pulmonary arterial hypertension and fit one of the listed guideline-based subtypes.[1] The migraine trial is for women with menstrually-related migraine, pure menstrual migraine, or perimenopausal migraine.[2]
These eligibility rules matter because they help researchers study the treatment in a more specific group of patients.[1][2] They also make it easier to understand which patients the results may apply to.[1][2]
Study design and phase
The PAH study is a Phase 3 interventional trial, which usually means a later-stage study that checks how a treatment performs in a larger group of patients.[1] The migraine study is described as a randomized controlled trial with a low-intervention design.[2]
Randomized means participants are assigned to treatment groups by chance, which helps make the comparison fair.[2] Open-label means the people in the study and the researchers know which treatment is being used.[2]
Across both studies, the research focus is not on the general properties of Alpha-Tocopherol, but on how it is being used within specific clinical trial settings.[1][2]
