Table of Contents
- Trial overview
- Adrenomyeloneuropathy trial
- Depression and insomnia trial
- Main endpoints and what they mean
- Who the trials are for
- Role of Magnesium Stearate in these trials
Trial overview
Two authorised interventional trials in the source data include Magnesium Stearate as part of the study products.[1][2] One trial is in people with adrenomyeloneuropathy, and the other is in patients with a major depressive episode and moderate to severe insomnia disorder.[1][2]
The trials have different phases: one is listed as Phase 4 and the other as Phase 3.[1][2] Their main goals are to measure clinical improvement, walking ability, and insomnia severity.[1][2]
Adrenomyeloneuropathy trial
The first study is titled Effect of dimethyl fumarate administered to patients with adrenomyeloneuropathy: a multicenter, placebo controlled, phase IIb/III trial.[1] It is authorised, interventional, and listed as Phase 4 in the source data.[1]
This trial is in people with adrenomyeloneuropathy, a long-term nerve and spinal cord condition.[1] The planned enrollment is 40 participants.[1]
The study medicine is dimethyl fumarate, and the trial compares it with placebo.[1] Magnesium Stearate appears in the intervention list as one of the tablet ingredients used in the study products.[1]
The primary endpoint is the mean change in the 2 Minute Walk Test (2MWT) between month 0 and month 24.[1] The same outcome is also checked at month 6, month 12, and at the end of the extension phase at month 36.[1]
The brief summary says the main objective is to show that dimethyl fumarate at 480 mg/day is better than placebo in improving the clinical condition of patients with AMN.[1]
Depression and insomnia trial
The second study is titled Study evaluating the efficacy and safety of daridorexant in patients with major depressive disorder and insomnia.[2] It is authorised, interventional, and listed as Phase 3.[2]
This trial includes patients with a major depressive episode and moderate to severe insomnia disorder.[2] The planned enrollment is 134 participants.[2]
The main treatment being studied is daridorexant, given by mouth.[2] Magnesium Stearate is listed among the oral tablet ingredients in the intervention record.[2]
The primary outcome is improvement in insomnia severity, measured by the Insomnia Severity Index (ISI) at 3 months.[2] The brief summary says the trial aims to evaluate the efficacy of daridorexant in improving insomnia in patients with major depressive disorder at 3 months.[2]
Main endpoints and what they mean
A primary endpoint is the main result a trial is designed to measure.[1][2] In the first trial, the primary endpoint is change in walking distance over time using the 2MWT.[1]
In the second trial, the primary endpoint is change in insomnia severity using the ISI score at 3 months.[2] These endpoints help researchers see whether the study treatment is linked to better function or symptom relief in the target group.[1][2]
Who the trials are for
The first trial is for people with adrenomyeloneuropathy.[1] The second trial is for patients with major depressive disorder and insomnia, specifically those with a major depressive episode and moderate to severe insomnia disorder.[2]
Because these are clinical trials, participation depends on the study rules and screening process set by each research team.[1][2] The source data do not give full eligibility details, so only the listed target populations can be confirmed.[1][2]
Role of Magnesium Stearate in these trials
In both records, Magnesium Stearate is listed as part of the intervention materials rather than as the main treatment being tested.[1][2] The main trial questions focus on dimethyl fumarate in one study and daridorexant in the other.[1][2]
This means the clinical research is centered on the study medicines and their effects in the chosen patient groups, while Magnesium Stearate appears as one component of the tablets used in the trial products.[1][2]
