Treating severe brain-injured patients with apomorphine : a behavioural and neuroimaging study

niversity of Liège0 sites54 target enrollmentAugust 9, 2018

Overview

No summary available.

Registry

who.int

Start Date

August 9, 2018

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Liège

•\- 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 6 weeks post\-insult
•\- Informed consent from patient or legal representative of the patient.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 35
•F.1\.3 Elderly (\>\=65 years) yes

•\- 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 2 weeks or 4 half\-lives of the drug.
•\- Use of neurological medications other than anti\-epileptic or anti\-spasticity drugs in the last 2 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) in the last 2 weeks or 4 half\-lives of the drug.
•\- 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 other than related to their acquired brain injury.
•\- 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)