Apomorphine in Severe Brain-injured Patients

Launched by UNIVERSITY OF LIEGE · Jan 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called apomorphine in patients who have severe brain injuries and are experiencing disorders of consciousness (DoC). The goal is to see if apomorphine can help improve these patients' awareness and responsiveness. The trial will involve 48 participants, who will be randomly assigned to receive either apomorphine or a placebo (a treatment that has no active ingredients). Researchers will evaluate how well the treatment works by measuring changes in patients' behavior and brain activity using various tests and imaging techniques.

To be eligible for the trial, participants must be between 18 and 80 years old, in a stable medical condition, and diagnosed with conditions like unresponsive wakefulness syndrome or a minimally conscious state. They should not be on certain medications that could interfere with the study. Throughout the trial, participants will undergo different assessments to monitor their responses to the treatment, and their progress will be followed over time. This study aims to provide valuable information about how apomorphine works and its potential to help improve the lives of patients with severe brain injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-80 years old.
• • Clinically stable, not dependent on medical ventilators for respiration.
• • Diagnosed as in an unresponsive wakefulness syndrome or minimally conscious state according to the international criteria and based on at least 2 consistent CRS-R in the last 14 days (one CRS-R in the last 7 days).
• • More than 4 weeks post-insult.
• • No serious neurological impairments others than related to their acquired brain injury.
• • No neurological medications other than anti-epileptic or anti-spasticity drugs within the last two weeks.
• • No use of dopaminergic medications other than apomorphine within the last two weeks.
• • Informed consent from legal representative of the patient (if patients recover, their consent will also be obtained).
• Exclusion Criteria:
• • Use of dopamine agonists or antagonists (e.g. amantadine, bromocriptine, l-dopa, pramipexole, ropinirole, amphetamine, bupropion, methylphenidate / risperidone, haloperidol, chlorpromazine, flupentixol, clozapine, olanzapine, quetiapine) in the last 4 weeks or 4 half-lives of the drug.
• • Use of drugs with known significant prolongation of the QT interval (e.g. class 1 antiarrythmics, sotalol, macrolides, quinolones, antipsychotic drugs, tricyclic antidepressants. Methadone, chloroquine, quinine)
• • A corrected QT interval over 480ms (calculated using Bazett's formula on a standard 12-lead ECG recorded in the last 14 days) or other risk factors for arrhythmia (congestive cardiac failure, severe hepatic impairment or significant electrolyte disturbance).
• • A history of previous neurological functional impairment.
• • Contraindication to MRI, EEG, or PET (e.g., electronic implanted devices, active epilepsy, external ventricular drain).
• • Use of nitrates or other vasodilators, central nervous system acting agents such as barbiturates, morphine and related drugs (relative exclusion criterion)