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|NCT03623828 : Treating Severe Brain-injured Patients With Apomorphine|
|Ages||Min: 18 Years Max: 55 Years|
- 18-55 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 (starting the apomorphine treatment at 10 weeks minimum)
- No serious neurological impairments others than related to their acquired brain
- 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).
- 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
- 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)
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03623828
| Link to official Clinicaltrials.gov listing