Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03623828 : Treating Severe Brain-injured Patients With Apomorphine
PhasePhase 2
AgesMin: 18 Years Max: 55 Years
Eligibility
Inclusion Criteria:

- 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
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)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03623828      |      Link to official Clinicaltrials.gov listing
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