Press release

First Patient in Clinical Trial on Promising Drug for Recovery of Consciousness


In Research

NeuroHealing Pharmaceuticals and the GIGA-Consciousness announce the treatment of the first patient in the clinical trial “Treating severe brain-injured patients with apomorphine: a behavioral and neuroimaging study.”

NeuroHealing Pharmaceuticals and the Coma Science Group at the GIGA-Consciousness, University of Liege announce the treatment of the first patient in the clinical trial: “Treating severe brain-injured patients with apomorphine: a behavioral and neuroimaging study.

The study (ClinicalTrials.gov Identifier: NCT03623828, EudraCT Identifier 2018-003144-23) will investigate the effects of subcutaneously administered apomorphine in brain-injured patients with disorders of consciousness. The study is designed to confirm previously observed positive clinical responses in these patients and to correlate behavioral improvements with multimodal neuroimaging techniques.  Results should help to define clearer guidelines in the treatment of patients with disorders of consciousness and allow a better understanding of how dopamine networks are involved in consciousness and its impairments.

The study is being conducted at the Coma Science Group and the William Lennox Neurological Hospital Center, Belgium. The Coma Science Group is one of the leading research centers in the world for the study of patients with altered states of consciousness. It aims to improve the medical care of patients in a coma, unresponsive wakefulness syndrome and minimally conscious states, as well as investigate the neural correlates of consciousness. William Lennox Neurological Hospital Center is a renowned hospital and an expertise center for the neurological rehabilitation of patients with disorders of consciousness.

Principal Investigator is Steven Laureys, M.D., PhD, Clinical Professor and Head of the Coma Science Group at the GIGA Institute of Liège, and Research Director at the Belgian National Fund for Scientific Research. He is recognized worldwide as a leading clinician and researcher in the field of neurology of consciousness.  He has over 450 papers in the field and has published several books including The Neurology of Consciousness (with Giulio Tononi, 2008, 2015); Coma Science (with A. Owen and N. Schiff; 2009) and Disorders of Consciousness (with N. Schiff, 2009).

Key members of the Belgium study research team include Study Chair Olivia Gosseries, Ph.D., Leandro Sanz, M.D., Nicolas Lejeune, M.D., Estelle Bonin, M.Sc., Séverine Blandiaux, M.Sc., et Aurore Thibaut, PhD.

« We are very excited to start this clinical trial which will assess in a controlled setting the efficacy of this promising drug for the treatment of this very challenging patient population. We currently have very limited therapeutic options to help patients recovering from coma and apomorphine could be a game-changer » says Steven Laureys, PI.

The stakes of this new clinical trial will be discussed along with currently available treatments and future therapeutic options in the frame of the “Coma Day : Quels traitements après le coma ?” in Liège on December 12, 2018.

Study Design

Previous studies (Fridman, et al 2009, 2010) have shown that apomorphine, a direct non-specific dopaminergic agonist, can dramatically improve the outcome of patients with disorders of consciousness within days to weeks of treatment. Notably, these patients had been previously treated with other dopaminergic agents, without response.

This study will investigate the response to a 30-day treatment regimen of daily subcutaneous infusions of apomorphine in patients with an unresponsive wakefulness syndrome or in a minimally conscious state. In an initial study phase, the treatment will be known by the physician and patient’s family (open-label), before a second phase with a placebo-controlled double-blind randomized design.

Outcome measures will include standardized behavioral assessments along with advanced multimodal brain imaging techniques, combining magnetic resonance imaging (MRI), positron emission tomography (PET), electroencephalography (EEG), actigraphy and core body temperature monitoring data. These techniques may help to identify a set of biomarkers that correlate with responsiveness to the therapy and pinpoint the neural networks targeted by dopamine agonists in these pathologies.

Patients will be monitored at baseline 30 days before initiation of therapy, during treatment and for 30 days after treatment washout. Long-term behavioral follow-up will be performed up to 2 years using structured phone interviews. Statistical analyses will be performed blindly to detect changes in behavioral status, circadian rhythmicity, brain metabolism and functional connectivity both at the individual and at the group level.

Further details

Sanz et al., (2018)Treating severely brain-injured patients with apomorphine: study protocol for a double blind randomized placebo-controlled trial using behavioral and neuroimaging assessments.”

The investigators want to thank Eurogenerics and Britannia Pharmaceuticals Ltd for their support to the study by providing clinical trial materials.

About GIGA Consciousness

The Coma Science Group at the GIGA-Consciousness aims to better understand and explain the origins of human consciousness by studying pathological, pharmacological and physiological modifications of conscious awareness in both patients and healthy subjects. Expertise ranges from the assessment of brain function in (i) brain death, coma, unresponsive wakefulness syndrome, minimally conscious state and locked-in syndrome patients to (ii) general anesthesia, controlled sedation and hallucinatory drugs, to (iii) hypnosis, meditation, near-death experiences and dream-like states.

Contacts

Olivia Gosseries, PhD et Leandro Sanz, MD
GIGA-Consciousness et Coma Science Group
Université de Liège et CHU de Liège, Belgique
ogosseries@uliege.be - Leandro.Sanz@uliege.be

Nicolas Lejeune, MD
GIGA-Consciousness et Coma Science Group
Institut de Neuroscience, UCLouvain
Centre Hospitalier Neurologique William Lennox, Groupe Hospitalier Saint-Luc, Ottignies, Belgique
nicolas.lejeune@uclouvain.be

Neal M. Farber, PhD
NeuroHealing Pharmaceuticals, Inc.
info@NeuroHealing.com - http://www.NeuroHealing.com

Image : From the article Cerveau : les seniors aussi fabriquent de nouveaux neurones, by Marie-Céline Ray in Futura-Sciences DR/

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