Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study on Apomorphine Hydrochloride and Sodium Chloride for Patients with Severe Brain Injury and Disorders of Consciousness

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on treating patients with a severe brain injury, specifically those experiencing a disorder of consciousness. The study will use a medication called apomorphine hydrochloride, which is administered as a solution for infusion through a subcutaneous injection. This means the medication is given under the skin. The purpose of the study is to understand how effective this treatment is for patients who have difficulty being aware of themselves or their surroundings due to their brain injury.

Participants in the study will receive either the apomorphine hydrochloride treatment or a placebo, which is a substance with no active medication. The study will last for a period of up to 30 days. During this time, researchers will monitor changes in the patients' conditions using various methods, including the Coma Recovery Scale, which helps assess the level of consciousness. Other assessments may include changes in brain activity measured by EEG (a test that detects electrical activity in the brain), and imaging techniques like MRI and PET scans, which provide detailed pictures of the brain.

The study aims to determine if apomorphine hydrochloride can improve the condition of patients with severe brain injuries by enhancing their level of consciousness. Researchers will also look at other factors such as sleep patterns and body temperature changes to gain a comprehensive understanding of the treatment's effects. The trial is expected to continue until 2028, providing valuable insights into the potential benefits of this treatment for individuals with severe brain injuries.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age between 18 and 70 years, clinical stability, and a diagnosis of unresponsive wakefulness syndrome or minimally conscious state.

    Informed consent is required from the patient or their legal representative.

  2. Step 2

    Initial assessment

    An initial assessment is conducted using the Coma Recovery Scale - Revised (CRS-R) to establish a baseline diagnosis.

    Additional assessments may include the Nociception Coma Scale - Revised (NCS-R) and various imaging and monitoring techniques such as EEG, PET, and MRI.

  3. Step 3

    Treatment administration

    The treatment involves the administration of apomorphine hydrochloride at a concentration of 5 mg/ml, delivered through a subcutaneous injection.

    The solution for infusion is prepared with sodium chloride 0.9%.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, regular monitoring is conducted to assess changes in diagnosis and other health indicators.

    This includes repeated assessments using the CRS-R and NCS-R, as well as ongoing EEG, PET, and MRI evaluations.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the change in diagnosis from the baseline as measured by the CRS-R.

    Secondary outcomes include changes in various scales and imaging results, such as EEG spectral power, PET signal quantification, and MRI functional connectivity.

  6. Step 6

    Completion of the trial

    The trial is estimated to conclude by September 15, 2028.

    Final assessments are conducted to evaluate the overall efficacy of the treatment and any changes in the patient's condition.

Who can join the trial?

6 criteria

  • Age between 18 and 70 years old.
  • Must be clinically stable, meaning their medical condition is not changing rapidly.
  • Diagnosed with an unresponsive wakefulness syndrome or minimally conscious state. These are conditions where a person has severe brain injury and shows limited awareness of themselves or their surroundings.
  • Diagnosis must be based on at least two consistent CRS-R tests in the last 14 days. CRS-R stands for Coma Recovery Scale-Revised, a tool used to assess the level of consciousness in people with severe brain injuries. One of these tests must be done in the last 7 days.
  • More than 4 weeks must have passed since the brain injury occurred.
  • Informed consent must be given by the patient or their legal representative. This means they agree to participate in the study after understanding what it involves.

Who cannot join the trial?

9 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who do not have a severe brain injury or disorder of consciousness.
  • Patients who are not able to provide informed consent or do not have a legal representative to do so on their behalf.
  • Patients who have medical conditions that could interfere with the study or its results.
  • Patients who are currently participating in another clinical trial.
  • Patients who have allergies or adverse reactions to the study medication, which is apomorphine hydrochloride.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of substance abuse or addiction.
  • Patients who have a serious medical condition that could affect their safety during the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Apomorphine is being studied for its potential to help patients with severe brain injuries who have disorders of consciousness. In this trial, it is administered through subcutaneous infusions, which means it is delivered under the skin. The goal is to see how effective it is in improving the patients' condition and to understand how many patients respond positively to this treatment.

What is already known about the treatment

Apomorphine – Apomorphine is administered through subcutaneous infusions, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in treating patients with severe brain injuries and disorders of consciousness. The main therapeutic indication is to improve consciousness levels in these patients. At the molecular level, apomorphine works by stimulating dopamine receptors in the brain, which can help enhance neural activity and potentially improve cognitive functions. It is classified pharmacologically as a dopamine agonist.

Investigated diseases

Disorder of Consciousness – This condition involves a significant impairment in awareness and responsiveness, often resulting from severe brain injury. It encompasses various states such as coma, vegetative state, and minimally conscious state. In a coma, individuals show no signs of wakefulness or awareness. In a vegetative state, patients may have sleep-wake cycles but lack awareness of themselves or their environment. The minimally conscious state is characterized by inconsistent but clear signs of awareness. The progression of these states can vary, with some individuals showing improvement over time, while others may remain in a prolonged state of impaired consciousness.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504631-40-01Estimated enrolment102 patientsSponsorCentre Hospitalier Universitaire De Liege

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.