Disorder of ConsciousnessPhase 2NCT03623828
Treating Severe Brain-injured Patients With Apomorphine
A Phase 2 study testing Apomorphine Hydrochloride 50Mg/10mL Prefilled Syringe in people with Disorder of Consciousness, run by University of Liege at 2 sites in Belgium.
Trial summary
Background: Patients who survive severe brain injury may develop chronic disorders of consciousness. Treating these patients to improve recovery is extremely challenging because of scarce and inefficient therapeutical options. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Apomorphine Hydrochloride 50Mg/10mL Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesBelgium
- Study dates
- 3 Oct 2018to 13 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital of Liège
Liège, 4000
Neurological Hospital Center William Lennox
Ottignies, Brabant Wallon, 1340
About this study
Official title: Treating Severe Brain-injured Patients With Apomorphine: a Behavioral and Neuroimaging Study
Background:
Patients who survive severe brain injury may develop chronic disorders of consciousness. Treating these patients to improve recovery is extremely challenging because of scarce and inefficient therapeutical options.
Read more
Among pharmacological treatments, apomorphine, a potent direct dopamine agonist, has exhibited promising behavioral effects, but its true efficacy and its mechanism remains unknown. This pilot study aims to verify the effects of apomorphine subcutaneous infusion in patients with disorders of consciousness, investigate the neural networks targeted by this treatment and evaluate the feasibility of a larger double-blind randomized placebo-controlled trial.
Methods/design:
This study is a prospective open-label pilot clinical trial. Six patients diagnosed with disorders of consciousness will be included to receive a 4-weeks regimen of daily subcutaneous infusions of apomorphine hydrochloride. Patients will be monitored for four weeks before the initiation of the therapy, closely during treatment and they will undergo a 4-weeks inpatient follow-up after washout, as well as a two-year long-term remote follow-up. Shortly before and after the treatment regimen, the subjects will receive a multimodal assessment battery including neuroimaging exams.
Primary outcome will be determined as behavioral response to treatment as measured by changes of diagnosis using the Coma Recovery Scale - Revised (CRS-R), while secondary outcome measures will include the Nociception Coma Scale - Revised (NCS-R, circadian rhythm modifications using actimetry, core body temperature recording and night electroencephalography (EEG), positron emission tomography (PET), resting-state high-density EEG and functional magnetic resonance imaging (fMRI). The Glasgow Outcome Scale - Extended (GOS-E) and a phone-adapted version of the CRS-R will be used for long-term follow-up.
Statistical analyses will focus on the detection of changes induced by apomorphine treatment at the individual level (comparing data before and after treatment) and at the group level (comparing responders with non-responders). Response to treatment will be measured at four different levels: 1. behavioral response (CRS-R, NCS-E, GOS-E), 2. brain metabolism (PET), 3. network connectivity (resting-state fMRI and high-density EEG) and 4. Circadian rhythm changes (actimetry, body temperature, night EEG).
Discussion:
Apomorphine is a promising and safe candidate for the treatment of disorders of consciousness but its efficacy, the profile of the responding population and its underlying mechanism remain to be determined. This pilot study will provide unprecedented data that will allow to investigate the response to apomorphine using multimodal methods and shed new light on the brain networks targeted by this drug in terms of metabolism, functional connectivity and behavioral response. The investigators aim to better define the phenotype of potential responders to identify them more easily and develop personalized patient management. This preliminary study will lay ground for a subsequent larger-scale placebo-controlled double-blind trial which will provide quantitative data on effect size controlled for spontaneous recovery.
- Conditions
- Disorder of Consciousness
- Being tested
- Apomorphine Hydrochloride 50Mg/10mL Prefilled Syringe
- Keywords
- unresponsive wakefulness syndrome, minimally conscious state, apomorphine, crs-r
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apomorphine Hydrochloride 50Mg/10mL Prefilled SyringeDrug
Also called APO-go PFS 5mg/ml
Product administered using an external continuous subcutaneous infusion pump.
| Study group | Role | What they receive |
|---|---|---|
| Apomorphine treatment | Experimental | Treatment by apomorphine hydrochloride subcutaneous infusion 12 hours per day during 30 days: 5-days titration phase (increasing doses from 0 to 4 mg/h), 7 days of maintenance at 4 mg/h and 18 days of maintenance phase with possible increase up to 6 mg/h if well tolerated.
Two days before the initiation of apomorphine, domperidone 20mg t.i.d per os (or via gastric tube) will be initiated to reduce common side effects. It will be maintained at least 7 days before an optional tapering off in the absence of nausea of vomiting. Receives: Drug: Apomorphine Hydrochloride 50Mg/10mL Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Coma Recovery Scale - Revised (CRS-R)
The CRS-R is a standardized validated neurobehavioral scale designed to assess patients with disorders of consciousness. It is divided in 6 subscales: Auditory Function (0-4 points), Visual Function (0-5 points), Motor Function (0-6 points), Oromotor/Verbal Function (0-3 points), Communication (0-2 points), Arousal (0-3 points). The subscores are summed to calculate a total score ranging from 0 to 23 points. Higher scores indicate better functions. More importantly, it provides the patient's diagnosis (coma, UWS, MCS-, MCS+, EMCS) based on the presence of specific items in different subscales (regardless of total score). Analyses will look for changes of diagnosis, changes of total score and changes of each subscore before, during and after apomorphine treatment.
Measured: up to 90 days (10x before treatment, 6x during treatment and 5x after treatment)
Secondary outcomes (10)
Nociception Coma Scale - Revised (NCS-R)
The NCS-R is a standardized validated scale designed to assess the perception of pain in patients with disorders of consciousness unable to functionally communicate. It is divided in 3 subscales: Motor Response (0-3 points), Verbal Response (0-3 points) and Facial Expression (0-3 points). The subscores are summed to calculate a total score ranging from 0 to 9 points. Higher scores indicate a higher perception of pain. Analyses will look for changes of total score and changes of each subscore before, during and after apomorphine treatment.
Measured: up to 90 days (5x before treatment, 4x during treatment and 5x after treatment)
resting-state EEG
Changes in EEG spectral power within fixed bands or dynamic connectivity using median spectral connectivity and graph-theoretic topology metrics (clustering coefficient, path length, modularity and participation coefficient) after apomorphine treatment.
Measured: up to 90 days (4x before treatment, 4x during treatment and 4x after treatment)
EEG with auditory paradigms
Multivariate classifier giving the probabilty to have signs of consciousness based on a machine-learning approach using 120 EEG markers.
Measured: up to 90 days
PET
Changes in quantification of PET signal using standardized uptake values of fluorodeoxyglucose after apomorphine treatment.
Measured: up to 90 days (1x before treatment and 1x after treatment)
fMRI
Changes in MRI functional connectivity using a seed-voxel approach, between regions of interest (here: striatum, globus pallidus interna, thalamus and prefrontal cortex) and the time course from all other brain voxels, after apormorphine treatment
Measured: up to 90 days (1x before treatment and 1x after treatment)
Circadian rythmycity using body movements
We use wrist actigraph recorded data on limb movements to calculate circadian rythmycity, measured in minutes. It corresponds to the period of the biological temporal rhythms with oscillations around 24 hours.
Measured: constant recording from enrollment up to 90 days
Circadian rythmycity using body temperature variations
We use data recorded from non-invasive body temperature measurement devices to calculate circadian rythmycity, measured in minutes. It corresponds to the period of the biological temporal rhythms with oscillations around 24 hours.
Measured: constant recording from enrollment up to 90 days
Number of sleep cycles using night EEG
We use data measured with whole-night EEG recordings to calculate the number of sleep cycles during one night and the duration spent in each phase of sleep.
Measured: actimetry and core body temperature recorded during the whole study; night EEG 1x before treatment initiation and 1x after treatment withdrawal
Glasgow Outcome Scale - Extended (GOS-E)
The GOS-E is a standardized validated scale designed to assess the the functional outcome of patients with disorders of consciousness. It is a single score ranging from 1 (dead) to 8 (upper good recovery). Higher scores indicate a higher functional recovery. It will be performed remotely by telephone contact with the patient or their relatives.
Analyses will look at differences in GOS-E score between responders and non-responders to apomorphine treatment, as well as differences in time within individual patients.
Measured: from 6 months post-treatment up to 24 months post-treatment (1x at 6 months, 1x at 12 months, 1x at 24 months)
Phone-adapted CRS-R
The phone-adapted CRS-R is a scale designed to assess remotely patients with disorders of consciousness. Unlike the CRS-R, it does not comprise subcores or a total score, but provides the clinical diagnosis of the patient (coma, UWS, MCS-, MCS+, EMCS) using the same diagnostic items as the CRS-R.
Analyses will look at differences in Phone-adapted CRS-R diagnosis between responders and non-responders to apomorphine treatment, as well as differences in time within individual patients.
Measured: from 6 months post-treatment up to 24 months post-treatment (1x at 6 months, 1x at 12 months, 1x at 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start3 Oct 2018
- Primary completion28 Apr 2021
- Study completion13 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label single-arm prospective pilot study. Included patients all undergo the same study protocol.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Université Catholique de Louvain
- Responsible party
- Principal investigator, Steven Laureys, University of Liege
- Investigators
- Steven Laureys, M.D., Ph.D., Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623828
- Sponsor's protocol ID
- 2017/81a
- Status last verified
- Feb 2022
- First submitted
- 25 Jul 2018
- Last updated
- 9 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fridman EA, Calvar J, Bonetto M, Gamzu E, Krimchansky BZ, Meli F, Leiguarda RC, Zafonte R. Fast awakening from minimally conscious state with apomorphine. Brain Inj. 2009 Feb;23(2):172-7. doi: 10.1080/02699050802649662.
PubMed 19191097Fridman EA, Krimchansky BZ, Bonetto M, Galperin T, Gamzu ER, Leiguarda RC, Zafonte R. Continuous subcutaneous apomorphine for severe disorders of consciousness after traumatic brain injury. Brain Inj. 2010;24(4):636-41. doi: 10.3109/02699051003610433.
PubMed 20235766Gosseries O, Charland-Verville V, Thonnard M, Bodart O, Laureys S, Demertzi A. Amantadine, apomorphine and zolpidem in the treatment of disorders of consciousness. Curr Pharm Des. 2014;20(26):4167-84.
PubMed 24025057Sanz LRD, Lejeune N, Szymkowicz E, Bonin EAC, Panda R, Sala A, Thibaut A, Huerta-Gutierrez R, Dardenne N, Dikenstein D, Van Goethem S, Ledoux D, Hustinx R, Stender J, Farber NM, Zafonte RD, Schiff ND, Laureys S, Gosseries O. Apomorphine for prolonged disorders of consciousness: a multimodal open-label study. EClinicalMedicine. 2024 Nov 15;78:102925. doi: 10.1016/j.eclinm.2024.102925. eCollection 2024 Dec.
PubMed 39624459Sanz LRD, Lejeune N, Blandiaux S, Bonin E, Thibaut A, Stender J, Farber NM, Zafonte RD, Schiff ND, Laureys S, Gosseries O. Treating Disorders of Consciousness With Apomorphine: Protocol for a Double-Blind Randomized Controlled Trial Using Multimodal Assessments. Front Neurol. 2019 Mar 19;10:248. doi: 10.3389/fneur.2019.00248. eCollection 2019.
PubMed 30941094
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Severe Brain-injured Patients With Apomorphine: a Behavioral and Neuroimaging Study
- ClinicalTrials.gov ID
- NCT03623828
- Acronym / sponsor ID
- 2017/81a
- Conditions
- Disorder of Consciousness
- Keywords
- unresponsive wakefulness syndrome, minimally conscious state, apomorphine, crs-r
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Université Catholique de Louvain
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 13 Nov 2022 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Patients who survive severe brain injury may develop chronic disorders of consciousness. Treating these patients to improve recovery is extremely challenging because of scarce and inefficient therapeutical options.
Among pharmacological treatments, apomorphine, a potent direct dopamine agonist, has exhibited promising behavioral effects, but its true efficacy and its mechanism remains unknown. This pilot study aims to verify the effects of apomorphine subcutaneous infusion in patients with disorders of consciousness, investigate the neural networks targeted by this treatment and evaluate the feasibility of a larger double-blind randomized placebo-controlled trial.
Methods/design:
This study is a prospective open-label pilot clinical trial. Six patients diagnosed with disorders of consciousness will be included to receive a 4-weeks regimen of daily subcutaneous infusions of apomorphine hydrochloride. Patients will be monitored for four weeks before the initiation of the therapy, closely during treatment and they will undergo a 4-weeks inpatient follow-up after washout, as well as a two-year long-term remote follow-up. Shortly before and after the treatment regimen, the subjects will receive a multimodal assessment battery including neuroimaging exams.
Primary outcome will be determined as behavioral response to treatment as measured by changes of diagnosis using the Coma Recovery Scale - Revised (CRS-R), while secondary outcome measures will include the Nociception Coma Scale - Revised (NCS-R, circadian rhythm modifications using actimetry, core body temperature recording and night electroencephalography (EEG), positron emission tomography (PET), resting-state high-density EEG and functional magnetic resonance imaging (fMRI). The Glasgow Outcome Scale - Extended (GOS-E) and a phone-adapted version of the CRS-R will be used for long-term follow-up.
Statistical analyses will focus on the detection of changes induced by apomorphine treatment at the individual level (comparing data before and after treatment) and at the group level (comparing responders with non-responders). Response to treatment will be measured at four different levels: 1. behavioral response (CRS-R, NCS-E, GOS-E), 2. brain metabolism (PET), 3. network connectivity (resting-state fMRI and high-density EEG) and 4. Circadian rhythm changes (actimetry, body temperature, night EEG).
Discussion:
Apomorphine is a promising and safe candidate for the treatment of disorders of consciousness but its efficacy, the profile of the responding population and its underlying mechanism remain to be determined. This pilot study will provide unprecedented data that will allow to investigate the response to apomorphine using multimodal methods and shed new light on the brain networks targeted by this drug in terms of metabolism, functional connectivity and behavioral response. The investigators aim to better define the phenotype of potential responders to identify them more easily and develop personalized patient management. This preliminary study will lay ground for a subsequent larger-scale placebo-controlled double-blind trial which will provide quantitative data on effect size controlled for spontaneous recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label single-arm prospective pilot study. Included patients all undergo the same study protocol.
| Arm | Type | Receives |
|---|---|---|
| Apomorphine treatment | Experimental | Drug: Apomorphine Hydrochloride 50Mg/10mL Prefilled SyringeTreatment by apomorphine hydrochloride subcutaneous infusion 12 hours per day during 30 days: 5-days titration phase (increasing doses from 0 to 4 mg/h), 7 days of maintenance at 4 mg/h and 18 days of maintenance phase with possible increase up to 6 mg/h if well tolerated. Two days before the initiation of apomorphine, domperidone 20mg t.i.d per os (or via gastric tube) will be initiated to reduce common side effects. It will be maintained at least 7 days before an optional tapering off in the absence of nausea of vomiting. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apomorphine Hydrochloride 50Mg/10mL Prefilled SyringeAlso: APO-go PFS 5mg/mlProduct administered using an external continuous subcutaneous infusion pump. | Drug | Apomorphine treatment |
Primary outcome
Change from baseline in Coma Recovery Scale - Revised (CRS-R)
Time frame: up to 90 days (10x before treatment, 6x during treatment and 5x after treatment)
The CRS-R is a standardized validated neurobehavioral scale designed to assess patients with disorders of consciousness. It is divided in 6 subscales: Auditory Function (0-4 points), Visual Function (0-5 points), Motor Function (0-6 points), Oromotor/Verbal Function (0-3 points), Communication (0-2 points), Arousal (0-3 points). The subscores are summed to calculate a total score ranging from 0 to 23 points. Higher scores indicate better functions. More importantly, it provides the patient's diagnosis (coma, UWS, MCS-, MCS+, EMCS) based on the presence of specific items in different subscales (regardless of total score). Analyses will look for changes of diagnosis, changes of total score and changes of each subscore before, during and after apomorphine treatment.
10 secondary outcomes
Nociception Coma Scale - Revised (NCS-R)
Time frame: up to 90 days (5x before treatment, 4x during treatment and 5x after treatment)
resting-state EEG
Time frame: up to 90 days (4x before treatment, 4x during treatment and 4x after treatment)
EEG with auditory paradigms
Time frame: up to 90 days
PET
Time frame: up to 90 days (1x before treatment and 1x after treatment)
fMRI
Time frame: up to 90 days (1x before treatment and 1x after treatment)
Circadian rythmycity using body movements
Time frame: constant recording from enrollment up to 90 days
Circadian rythmycity using body temperature variations
Time frame: constant recording from enrollment up to 90 days
Number of sleep cycles using night EEG
Time frame: actimetry and core body temperature recorded during the whole study; night EEG 1x before treatment initiation and 1x after treatment withdrawal
Glasgow Outcome Scale - Extended (GOS-E)
Time frame: from 6 months post-treatment up to 24 months post-treatment (1x at 6 months, 1x at 12 months, 1x at 24 months)
Phone-adapted CRS-R
Time frame: from 6 months post-treatment up to 24 months post-treatment (1x at 6 months, 1x at 12 months, 1x at 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Background: PubMed 19191097Fridman EA, Calvar J, Bonetto M, Gamzu E, Krimchansky BZ, Meli F, Leiguarda RC, Zafonte R. Fast awakening from minimally conscious state with apomorphine. Brain Inj. 2009 Feb;23(2):172-7. doi: 10.1080/02699050802649662.
- Background: PubMed 20235766Fridman EA, Krimchansky BZ, Bonetto M, Galperin T, Gamzu ER, Leiguarda RC, Zafonte R. Continuous subcutaneous apomorphine for severe disorders of consciousness after traumatic brain injury. Brain Inj. 2010;24(4):636-41. doi: 10.3109/02699051003610433.
- Background: PubMed 24025057Gosseries O, Charland-Verville V, Thonnard M, Bodart O, Laureys S, Demertzi A. Amantadine, apomorphine and zolpidem in the treatment of disorders of consciousness. Curr Pharm Des. 2014;20(26):4167-84.
- Derived from this study: PubMed 39624459Sanz LRD, Lejeune N, Szymkowicz E, Bonin EAC, Panda R, Sala A, Thibaut A, Huerta-Gutierrez R, Dardenne N, Dikenstein D, Van Goethem S, Ledoux D, Hustinx R, Stender J, Farber NM, Zafonte RD, Schiff ND, Laureys S, Gosseries O. Apomorphine for prolonged disorders of consciousness: a multimodal open-label study. EClinicalMedicine. 2024 Nov 15;78:102925. doi: 10.1016/j.eclinm.2024.102925. eCollection 2024 Dec.
- Derived from this study: PubMed 30941094Sanz LRD, Lejeune N, Blandiaux S, Bonin E, Thibaut A, Stender J, Farber NM, Zafonte RD, Schiff ND, Laureys S, Gosseries O. Treating Disorders of Consciousness With Apomorphine: Protocol for a Double-Blind Randomized Controlled Trial Using Multimodal Assessments. Front Neurol. 2019 Mar 19;10:248. doi: 10.3389/fneur.2019.00248. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Laureys, M.D., Ph.D. principal investigator
Centre Hospitalier Universitaire de Liege
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apomorphine Hydrochloride 50Mg/10mL Prefilled Syringe in people with Disorder of Consciousness, run by University of Liege at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Coma Recovery Scale - Revised (CRS-R) (time frame: up to 90 days (10x before treatment, 6x during treatment and 5x after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03623828, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.