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Apomorphine in Severe Brain-injured Patients

RecruitingPhase 2, Phase 3Ages 18 Years - 80 YearsAllUniversity of Liege
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In plain words

What the trial is, and whether it could suit you

Background: Patients who survive severe brain injury may develop chronic disorders of consciousness (DoC). Treating these patients to improve recovery is extremely challenging because of scarce and inefficient therapeutical options. Among pharmacological treatments, apomorphine, a potent direct dopamine agonist, has exhibited promising behavioral effects, but its true efficacy and its mechanism remains unknown. This randomized controlled study aims to verify the effects of apomorphine subcutaneous infusion in patients with disorders of consciousness and investigate the neural networks targeted by this treatment. Methods/design: The double-blind randomized controlled trial will include 48 patients: 24 patients will be randomly assigned to the apomorphine and 24 to the placebo group. Investigators and the patients will be unaware of the nature of the treatment rendered. Primary outcome

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📋 Eligibility rules (as published)
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)
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What it tests

  • Apomorphine Hydrochloride 5mg/ml
  • Sodium chloride 9mg/ml
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Where

4 sites
University of Liege
Liège, Belgium
Hôpital Valdor - ISoSL
Liège, Belgium
Centre Hospitalier Neurologique William Lennox
Ottignies-Louvain-la-Neuve, Belgium
VITHAS
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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