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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Virgen Del Consuelo Valencia Spain
Hospital Nisa Sevilla Aljarafe Castilleja De La Cuesta Spain
Vithas Hospital Nosa Senora De Fatima Vigo Spain
Cyeume Ndlnenehfgpb Wxqkpgr Lguqxz Ottignies Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.09.2018
Spain Spain
Not yet recruiting
15.09.2018

Trial locations

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.

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 ID:
2023-504631-40-01
NCT ID:
NCT05213169
Trial Phase:
Therapeutic exploratory (Phase II)

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