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    Summary
    EudraCT Number:2021-006486-38
    Sponsor's Protocol Code Number:ComplexitDOC_PSI
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-06-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-006486-38
    A.3Full title of the trial
    Complexity-enhancing drugs to treat disorders of consciousness (DoC): a psilocybin study
    Agents pharmacologiques augmentant la complexité cérébrale pour traiter les troubles de la conscience après un coma (TDC) : étude sur la psilocybine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Psilocybin to treat patients with post-comatose disorders of consciousness
    A.3.2Name or abbreviated title of the trial where available
    ComplEXIT-DOC_PSI
    A.4.1Sponsor's protocol code numberComplexitDOC_PSI
    A.5.4Other Identifiers
    Name:Ethical Committee - University Hospital of LiègeNumber:2021-414
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Liege
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity of Liège
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportFonds Léon Fredericq
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportFonds de la Recherche Scientifique – FNRS
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Liege
    B.5.2Functional name of contact pointComa Science Group
    B.5.3 Address:
    B.5.3.1Street AddressGIGA B34, Avenue de l'Hopital 1
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.6E-mailcoma@uliege.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePEX010 (Psilocybin Capsules 25mg)
    D.3.2Product code PEX010
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDry extract from Psilocybe cubensis (15-25:1), Extraction solvent: methanol
    D.3.9.3Other descriptive namePYEX
    D.3.9.4EV Substance CodeSUB267722
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Disorders of consciousness as unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) after a coma due to acquired brain injury.
    Troubles de la conscience tels que le syndrome d'éveil non repondant (ENR) et l'état de conscience minimale (ECM) après un coma dû d'une lésion cérébrale acquise.
    E.1.1.1Medical condition in easily understood language
    Disorders of consciousness
    Troubles de l'état de conscience
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This clinical trial aims to evaluate the efficacy of oral psilocybin for the treatment of patients with disorders of consciousness (DoC) after a coma and assess the prevalence of responders.
    Cet essai clinique vise à évaluer l'efficacité de la psilocybine par voie orale comme traitement pour les patients présentant des troubles de la conscience post-coma et mesurer la prévalence des répondeurs.
    E.2.2Secondary objectives of the trial
    This study aims to also better characterize the phenotype of potential good candidates to psilocybin treatment and identify a set of biomarkers that correlate with responsiveness (or non-responsiveness) to the therapy, as well to help underpinning the neural networks underlying the modulating action of psilocybin on consciousness and brain complexity.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pilot study on healthy participants:
    - Title: "Psilocybin to treat patients with post-comatose disorders of consciousness: pilot on healthy participants"
    -N: 20 subjects

    Study on DoC patients:
    - Title: "Psilocybin to treat patients with post-comatose disorders of consciousness"
    - N: 30 patients
    E.3Principal inclusion criteria
    Inclusion criteria for healthy participants
    - 18-55 years old
    - No history of psychiatric, psychotic or neurologic disorders
    - No history of psychiatric disorders in first-degree relatives

    Inclusion criteria for DoC patients
    - 18-55 years old
    - No history of psychiatric or psychotic in first-degree relatives
    - Clinically stable, not dependent on medical ventilators for respiration
    - Diagnosed as in an UWS or MCS according to the international criteria and based on at least 2 consecutive SECONDs/CRS-R
    - More than 28 days post-insult
    E.4Principal exclusion criteria
    Exclusion criteria for healthy participants:
    - Excessive use of alcohol (>30 units per week)
    - Renal failure
    - Coronary insufficiency
    - Pregnancy
    - Use of medication within the week before the experiment unless prescribed by general practitioner and with no interaction with the nervous system
    - History of stroke
    - Current angina
    - Uncontrolled hypertension
    - Abnormal electrical activity of the heart (ECG) (e.g. atrial fibrillation)
    - Artificial heart valve
    - Transient ischemic attack within the last year
    - Current epilepsy

    Exclusion criteria:
    - History of previous neurological impairment other than related to their acquired brain injury
    - History of psychiatric or psychotic disorders
    - Renal failure
    - Coronary insufficiency
    - Contraindication to MRI, EEG, or PET (e.g., electronic implanted devices, external ventricular drain)
    - Use of serotoninergic agonists or antagonists (e.g., selective serotonin reuptake inhibitors, serotonin–norepinephrine reuptake inhibitors)
    - Ritonavir (Norvir), an anti-retroviral medication used to treat HIV
    - Tricyclic antidepressants, such as amitriptyline and nortriptyline (Pamelor)
    - Monoamine oxidase inhibitors (MAOIs), antidepressants such as isocarboxazid (Marplan) and phenelzine (Nardil)
    - Current angina
    - Uncontrolled hypertension
    - Artificial heart valve
    - Transient ischemic attack within the last year
    - Pregnancy
    - Current epilepsy
    - Diabetes or obesity
    E.5 End points
    E.5.1Primary end point(s)
    New signs of consciousness assessed via the Simplified Evaluation of CONsciousness Disorders (SECONDs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two sessions separated by 5 days
    E.5.2Secondary end point(s)
    1-Change of complexity measured with the Lempel-Ziv Complexity
    2-Changes in EEG spectral power within fixed bands or dynamic connectivity using median spectral connectivity and graph-theoretic topology metrics
    3-Changes in the probability of consciousness using a multivariate EEG
    a classifier based on a machine-learning approach using 120 EEG markers
    4-Difference of PET, MRI, or EEG in the baseline assessment between responders and not-responders
    E.5.2.1Timepoint(s) of evaluation of this end point
    Recording with EEG done from 20 minutes before giving psilocybin to a maximum of 150 minutes drug intake
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Theoretical proof-of-concept for link between complexity and consciousness
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last follow-up phone call of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-06-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with DoC, more specifically with UWS or MCS. Consent will be given by the legal representative. If the patient recovers s/he will be asked directly.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients might be included for other treatments currently available or studied (i.e., apomorphine or zolpidem) after a wash-out period of 4 weeks.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2025-01-01
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