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ZOLPIDEM TARTRATE

ZOLPIDEM TARTRATE clinical trials are studying how some people have unusual, or paradoxical, responses to this medicine. The trial data focus on safety and effects in patients with disorders of consciousness, people with acquired vision impairment, and healthy volunteers. The goal is to better understand who responds and what changes are measured in the brain, alertness, and function.

Table of contents

Trial overview

This source describes one interventional study, which means the researchers give a study treatment and then measure what happens.[1] The trial title is “Mechanisms of Action of Paradoxical Responses to Zolpidem: A Multimodal Study.”[1] The study status is Suspended, so it is not currently moving ahead as planned.[1]

Who is being studied

The trial includes three groups: patients with disorders of consciousness (DoC), patients with acquired partial or total vision impairment, and neurotypical volunteers, which means people from the general population used for comparison.[1] The brief summary says the researchers are interested in people who may show a paradoxical response to ZOLPIDEM TARTRATE, meaning an unexpected response rather than the usual one.[1]

In the DoC group, the researchers are looking at whether some participants may recover consciousness after the study intervention.[1] In the vision-impaired group, they are looking at whether some participants may have a temporary return of vision.[1] In neurotypical volunteers, the summary notes possible changes such as trouble falling asleep, higher concentration, and increased agitation in paradoxical responders.[1]

What is being measured

The main outcomes are different for each group, but they all help researchers understand response patterns.[1] For patients with DoC, the study measures consciousness level using the Coma Recovery Scale-Revised (CRS-R), brain complexity using high density electroencephalography (hdEEG), and patient experiences through free recall or interview if functional communication returns.[1]

For neurotypical volunteers, the study measures alertness or sleepiness with the Karolinska Sleepiness Scale (KSS), cognitive performance with standardised neuropsychological tests, brain complexity with hdEEG, and any reported experiences through free recall or interview.[1] For patients with acquired vision impairment, the same alertness, cognitive, brain, and experience measures are used, plus visual function testing by a neuro-ophthalmologist, who is an eye specialist focused on the nervous system and vision.[1]

Study design and phase

The study is listed as Phase 2.[1] Phase 2 studies usually look more closely at whether a treatment has an effect in the target groups and continue to collect information about outcomes.[1] The planned enrollment is 180 participants.[1]

The intervention list includes Zolpidem Viatris 10 mg tablets and mannitol, with administration by oral, nasogastric tube, or percutaneous endoscopic gastrostomy tube use as stated in the source.[1] The source does not provide more detail on dosing schedules beyond this listing.[1]

Why this research matters

The brief summary says the study aims to better understand the mechanisms behind paradoxical responders versus non-paradoxical responders to ZOLPIDEM TARTRATE.[1] This matters because the same treatment may lead to very different results across people, and the researchers want to learn which brain, behavior, or vision changes may help explain those differences.[1] The summary also says the findings could support improved personalised patient care.[1]

Trial ID Phase Condition studied Status Enrollment
2023-507404-31-03 Phase 2 Disorders of consciousness, acquired vision impairment, neurotypical volunteers Suspended 180

FAQ

  • What is being studied in ZOLPIDEM TARTRATE clinical trials? The trial is studying paradoxical responses, which means the expected effect is not always what happens. Researchers want to understand why some people show recovery of consciousness, better vision, or changes in alertness after taking ZOLPIDEM TARTRATE.
  • Who can take part in this study? The trial includes three groups: patients with disorders of consciousness, patients with acquired partial or total vision impairment, and neurotypical volunteers. These groups help researchers compare responses across different types of participants.
  • What phase is the ZOLPIDEM TARTRATE trial? This study is a Phase 2 trial. Phase 2 studies usually look more closely at how a treatment works in specific groups and continue to gather safety and effect information.
  • What outcomes are measured in the trial? The study measures consciousness level, brain activity and complexity, alertness or sleepiness, cognitive performance, vision function, and patient-reported experiences. These outcomes help show whether the response is temporary and how it affects daily function.
  • What is the current status of the trial? The trial status is suspended. This means the study is not currently moving forward as planned.

Ongoing Clinical Trials on ZOLPIDEM TARTRATE

  • Study on Zolpidem’s Effects in Patients with Vision Impairments, Disorders of Consciousness, and Neurotypical Volunteers

    Not yet recruiting

    2 1 1
    Investigated drugs:
    Belgium

Glossary

  • Paradoxical response: An unexpected response to a treatment. In this study, some people may improve in ways that are not the usual effect of ZOLPIDEM TARTRATE.
  • Disorders of consciousness (DoC): A group of serious brain conditions where a person has reduced awareness or wakefulness.
  • Acquired vision impairment: Vision loss that happens after birth, not present from the start of life.
  • Neurotypical volunteers: People from the general population without the conditions being studied, used for comparison in research.
  • Phase 2: A trial stage that looks more closely at whether a treatment has an effect in a specific group of people.
  • Primary outcome: The main result the researchers plan to measure to answer the study question.
  • Coma Recovery Scale-Revised (CRS-R): A test used to measure level of consciousness in people with disorders of consciousness.
  • High density electroencephalography (hdEEG): A brain test that records electrical activity from many points on the scalp to study brain complexity.
  • Karolinska Sleepiness Scale (KSS): A scale used to measure how sleepy or alert a person feels.
  • Ophthalmological testing: Eye testing done by a specialist to measure visual function.
  • Functional communication: The ability to communicate in a useful way, such as answering questions or sharing experiences.

References

  1. https://clinicaltrials.gov/study/2023-507404-31-03