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    Summary
    EudraCT Number:2020-001348-25
    Sponsor's Protocol Code Number:COMP004
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-03
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-001348-25
    A.3Full title of the trial
    A multicentre study to assess safety and efficacy of COMP360 in patients with treatment-resistant depression following completion of COMP 001 and COMP 003 trials (P-TRD LTFU)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long Term Follow up study for subjects that participated in COMP001 and COMP003 trial
    A.4.1Sponsor's protocol code numberCOMP004
    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 SponsorCOMPASS Pathfinder, Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCOMPASS Pathfinder, Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCOMPASS Pathfinder, Ltd.
    B.5.2Functional name of contact pointEkaterina Malievskaia
    B.5.3 Address:
    B.5.3.1Street Address3rd Floor, 1 Ashley Road, Altrincham
    B.5.3.2Town/ cityCheshire
    B.5.3.3Post codeWA14 2DT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number079 2087 6562
    B.5.6E-mailkatya@compasspathways.com
    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 namePsilocybin 5 mg
    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 INNPSILOCYBIN
    D.3.9.1CAS number 520-52-5
    D.3.9.3Other descriptive namePsilocybin
    D.3.9.4EV Substance CodeSUB198754
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 namePsilocybin 1 mg
    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 INNPSILOCYBIN
    D.3.9.1CAS number 520-52-5
    D.3.9.3Other descriptive namePSILOCYBIN
    D.3.9.4EV Substance CodeSUB198754
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Treatment-Resistant Depression (P-TRD)
    E.1.1.1Medical condition in easily understood language
    Treatment-Resistant Depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025463
    E.1.2Term Major depressive disorder, single episode
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025454
    E.1.2Term Major depressive disorder, recurrent episode
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the long-term efficacy of COMP360 with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg COMP360 groups from COMP 001).
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    •To assess response, sustained response, remission and change in depression severity (compared across all treatment groups – 1 mg, 10 mg and 25 mg COMP360 in COMP 001 and 25 mg as an adjunct to SSRIs in COMP 003) over a total of 52 weeks
    •To evaluate the effect of COMP360 on functioning and associated disability compared across the groups over a total of 52 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Signed ICF
    2)Each participant having completed the final study visit of either COMP 001 or COMP 003
    3)Ability to complete all protocol required assessment tools (including having access to the internet in order to complete the digital assessments) without any assistance or alteration to the copyrighted assessments, and to comply with all study visits
    E.4Principal exclusion criteria
    1)Subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject eg participation could compromise the wellbeing of the participant or prevent, limit, or confound the protocol-specified assessments
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this long-term follow up study will be time to the first of any of the following depression-related events (from baseline ie one day prior to single dose COMP360 administration dosing in the prior study) in participants recruited from the COMP 001 study (presented for the 1 mg , 10 mg, and 25 mg COMP360 therapy groups):
    •Initiation of new antidepressant treatment (first new antidepressant treatment in time period only)
    •Hospitalisation due to depression
    •Suicide attempt, prevention of an imminent suicide attempt, or completed suicide
    •Increased suicidality measured by worsening on MADRS item 10 i.e. either 1) a score of 5 or 6 on MADRS item 10; or 2) an increase of 2 points compared to Baseline in the prior study MADRS 10 score provided the score is ≥3
    •Worsening in the MADRS clinician rated severity scale: i.e. a 5 point worsening compared to baseline score in the prior study at any timepoint post-baseline of the original study; or a worsening of ≥5 points (providing the highest score is ≥15) across two or more consecutive visits (in this case the first date of the ≥5 point increase will be classed as the event and at the final study visit the ≥5 point worsening will qualify as an event without need for confirmation at a subsequent visit)
    E.5.1.1Timepoint(s) of evaluation of this end point
    31JUL2022
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    •Change in MADRS total score from Baseline of the prior study to 12 , 16, 20, 24, 28. 40, and 52 weeks post COMP360
    •The proportion of participants with a response (defined as a ≥ 50% improvement in MADRS total score from Baseline of the prior study) at Week 12 , 16, 20, 24, 28, 40, and 52 post COMP360
    •The proportion of participants with remission (defined as a MADRS total score ≤ 10) at Week 12, 16, 20, 24, 28, 40, and 52 post COMP360
    •The proportion of participants who have a sustained response at Week 12, 16, 20, 24, 28, 40 and 52. Sustained response is defined as the proportion of patients fulfilling response criteria at any visit up to and including Week 3 post-dosing (in the lead-in studies), that also fulfills response criteria at all subsequent visits up to and including Week 12, 16, 20, 24, 28, 40, and 52 post COMP360. Response is defined as ≥ 50% decrease in MADRS total score from Baseline of the prior study
    •Longitudinal depression severity: the difference in the area under the curve between 1mg, 10 mg, and 25 mg COMP360 monotherapy and 25 mg COMP360 adjunctive therapy over 52 weeks post-baseline in QIDS-SR-16 total score
    •Work and Social Adjustment (WSAS) score change from Baseline of the prior study to week 12, 18, 24, 30, 36, 42, 48
    •Sheehan Disability Scale (SDS) score change from Baseline of the prior study to week 12, 16, 20, 24, 28, 40, and 52 post COMP360
    E.5.2.1Timepoint(s) of evaluation of this end point
    31JUL2022
    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 No
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Long term Follow up
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial0
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    Denmark
    Ireland
    Netherlands
    Portugal
    Spain
    United Kingdom
    Czechia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 150
    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)
    Back to standard care as per local clinical practice
    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 Decision2020-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-11
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