Using apomorphine to treat severe brain injury patients with disorders of consciousness
Randomized Controlled Trial of Apomorphine in Severe Brain-injured Patients: a Double-blind Behavioral and Neuroimaging Study
This study is testing if a medication called apomorphine can help patients with severe brain injuries who have trouble being aware of their surroundings.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Liege Academic / other |
| Locations | 4 sites (Liège, Liege and 3 other locations) |
| Trial ID | NCT05213169 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who are clinically stable and diagnosed with an unresponsive wakefulness syndrome or minimally conscious state.
Not a fit: Patients with serious neurological impairments unrelated to their brain injury or those currently using certain dopaminergic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with severe brain injuries.
How similar studies have performed: While the use of apomorphine in this context is novel, previous studies have shown promising behavioral effects of dopamine agonists in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Liège, Liege and 3 other locations
- University of Liege — Liège, Liege, Belgium (Active_not_recruiting)
- Hôpital Valdor - ISoSL — Liège, Liège, Belgium (Recruiting)
- Centre Hospitalier Neurologique William Lennox — Ottignies-Louvain-la-Neuve, Belgium (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.