Status:
RECRUITING
Apomorphine in Severe Brain-injured Patients
Lead Sponsor:
University of Liege
Collaborating Sponsors:
Centre Hospitalier Neurologique William Lennox (Belgium)
Hôpital Valdor - ISoSL (Belgium)
Conditions:
Disorder of Consciousness
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05213169
Start Date
June 18 2021
End Date
December 31 2026
Last Update
April 15 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Liege
Liège, Liege, Belgium, 4000
2
Hôpital Valdor - ISoSL
Liège, Liège, Belgium, 4000
3
Centre Hospitalier Neurologique William Lennox
Ottignies-Louvain-la-Neuve, Belgium, 1340
4
VITHAS
Valencia, Spain, 46035