Fast awakening from minimally conscious state with apomorphine.
Esteban A Fridman, Jorge Calvar, Mariana Bonetto...
https://pubmed.ncbi.nlm.nih.gov/19191097Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 80Years
All Genders
ID05213169
Randomized Controlled Trial of Apomorphine in Severe Brain-injured Patients: a Double-blind Behavioral and Neuroimaging Study
Led by University of Liege · Updated on 2025-04-15
48
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Liege
Lead Sponsor
C
Centre Hospitalier Neurologique William Lennox (Belgium)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of apomorphine, a dopamine agonist, in patients who have survived severe brain injuries and developed chronic disorders of consciousness (DoC). This randomized controlled trial aims to verify the impact of apomorphine subcutaneous infusion on behavioral recovery and to study the brain networks involved in the treatment response. The study addresses the urgent need for effective therapies in this challenging patient population. Participants will be randomly assigned to receive either apomorphine hydrochloride or a placebo via continuous subcutaneous infusion pump. The apomorphine group undergoes a 30-day treatment with a titration phase increasing from 0 to 4 mg/h over 5 days, followed by 18 days at 4 mg/h or up to 6 mg/h depending on tolerance. Domperidone is administered to reduce side effects starting 2 days before apomorphine. The placebo group receives a sodium chloride infusion following the same schedule. Throughout the study, participants will be closely monitored using multiple behavioral scales including the Coma Recovery Scale - Revised and others to assess response to treatment. Brain function and metabolism will be evaluated with EEG, PET, and fMRI scans. Circadian rhythms will be tracked using actimetry and body temperature. Long-term outcomes will be followed up to 24 months post-treatment using phone assessments. Safety and efficacy data will be analyzed at both individual and group levels over a 90-day treatment and observation period.
CONDITIONS
Brief Title
Apomorphine in Severe Brain-injured Patients
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Clinically stable and not dependent on medical ventilators for breathing
- Diagnosed with unresponsive wakefulness syndrome or minimally conscious state based on at least two consistent Coma Recovery Scale - Revised assessments in the last 14 days
- More than 4 weeks have passed since brain injury
- No serious neurological impairments other than those related to acquired brain injury
- No neurological medications except anti-epileptic or anti-spasticity drugs within the last two weeks
- No dopaminergic medications except apomorphine within the last two weeks
- Informed consent obtained from legal representative (and from patient if recovered)
You will not qualify if you...
- Use of dopamine agonists or antagonists within the last 4 weeks or 4 half-lives of the drug
- Use of drugs known to significantly prolong QT interval
- Corrected QT interval over 480ms or risk factors for arrhythmia
- History of previous neurological functional impairment
- Contraindications to MRI, EEG, or PET such as implanted electronic devices or active epilepsy
- Use of nitrates, vasodilators, barbiturates, morphine, or related drugs (relative exclusion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 30 days
Participants receive apomorphine hydrochloride or placebo by continuous subcutaneous infusion for 12 hours per day during 30 days, including a titration phase and maintenance phase. Domperidone is given to reduce side effects starting 2 days before infusion.
Daily visits or assessments during the 30-day infusion period
Follow-up
Duration - Up to 60 days after treatment
Participants are monitored for safety and recovery outcomes after treatment completion, including neuroimaging and functional assessments up to 90 days post-treatment.
Multiple visits for assessments including neuroimaging and clinical scales
Long-term Monitoring
Duration - Up to 24 months
Participants undergo periodic assessments of functional recovery using phone-adapted scales and outcome measures at 6, 12, and 24 months post-treatment.
3 phone assessments at 6, 12, and 24 months post-treatment
Trial Site Locations
Total: 4 locations
1
University of Liege
Liège, Liege, Belgium, 4000
Active, Not Recruiting
2
Hôpital Valdor - ISoSL
Liège, Liège, Belgium, 4000
Actively Recruiting
3
Centre Hospitalier Neurologique William Lennox
Ottignies-Louvain-la-Neuve, Belgium, 1340
Actively Recruiting
4
VITHAS
Valencia, Spain, 46035
Not Yet Recruiting
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Research Team
E
Emilie Szymkowicz, MSc.
L
Leandro RD Sanz, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Continuous subcutaneous apomorphine for severe disorders of consciousness after traumatic brain injury.
Esteban A Fridman, Ben Zion Krimchansky, Mariana Bonetto...
https://pubmed.ncbi.nlm.nih.gov/20235766Amantadine, apomorphine and zolpidem in the treatment of disorders of consciousness.
Olivia Gosseries, Vanessa Charland-Verville, Marie Thonnard...
https://pubmed.ncbi.nlm.nih.gov/24025057Treating Disorders of Consciousness With Apomorphine: Protocol for a Double-Blind Randomized Controlled Trial Using Multimodal Assessments.
Leandro R D Sanz, Nicolas Lejeune, Séverine Blandiaux...
https://pubmed.ncbi.nlm.nih.gov/30941094