Using apomorphine to treat severe brain injury patients with disorders of consciousness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of apomorphine, a dopamine agonist, on patients suffering from disorders of consciousness, such as unresponsive wakefulness syndrome and minimally conscious state. The study will randomly assign 48 patients to receive either apomorphine or a placebo in a double-blind manner, ensuring that neither the participants nor the investigators know which treatment is being administered. The primary outcome will focus on behavioral responses to treatment, assessed through changes in diagnosis based on standardized assessments. The trial aims to uncover the efficacy of apomorphine and the neural mechanisms involved in its action.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hôpital Valdor - ISoSL
  Liège, Liège, Belgium Recruiting
• Centre Hospitalier Neurologique William Lennox
  Ottignies-Louvain-la-Neuve, Belgium Recruiting
• University of Liege
  Liège, Liege, Belgium Active not recruiting
• Vithas
  Valencia, Spain Not yet recruiting

Study contacts

• Principal investigator: Olivia Gosseries, Ph.D. — University of Liege
• Study coordinator: Emilie Szymkowicz, MSc.
• Email: emilie.szymkowicz@uliege.be
• Phone: +32492319947

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.