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    Summary
    EudraCT Number:2019-003623-37
    Sponsor's Protocol Code Number:CAN-PDP
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-01-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-003623-37
    A.3Full title of the trial
    CANnabidiol for Parkinson’s Disease Psychosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CANnabidiol for Parkinson’s Disease Psychosis
    A.3.2Name or abbreviated title of the trial where available
    CAN-PDP
    A.4.1Sponsor's protocol code numberCAN-PDP
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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 supportParkinson's UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointProf Sagnik Bhattacharyya
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Psychosis Studies
    B.5.3.2Town/ city Main IoPPN Building, De Crespigny Park
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442078480955
    B.5.6E-mailsagnik.2.bhattacharyya@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorSouth London and Maudsley NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportParkinson's UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointProf Sagnik Bhattacharyya
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Psychosis Studies
    B.5.3.2Town/ city Main IoPPN Building, De Crespigny Park
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442078480955
    B.5.6E-mailsagnik.2.bhattacharyya@kcl.ac.uk
    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 nameCannabidiol
    D.3.2Product code Cannabidiol
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCannabidiol (CBD)
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor codeCannabidiol (CBD)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 1000
    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, hard
    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
    Parkinson's disease psychosis
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease psychosis
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074835
    E.1.2Term Parkinson's disease psychosis
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part I: To evaluate the safety and tolerability of CBD as a treatment in patients with Parkinson’s disease and psychosis (PDP) and identify the maximum tolerated dose (MTD).

    PART II: To evaluate the safety and tolerability of the most appropriate dose level of CBD (as identified from Part I study) compared to matched placebo treatment in people with PDP.



    E.2.2Secondary objectives of the trial
    PART I:
    (i) To examine whether there is any evidence of drug-drug interaction with any of the safe and tolerated doses of CBD when given to people with PDP.
    (ii) To identify safe and tolerated doses of CBD treatment for people with PDP that show any pharmacodynamic signal.
    The most appropriate dose to be taken into Part II will be based on a full review of MTD, safety, tolerability and drug activity.


    PART II:
    (i)To obtain proof-of-concept evidence of activity of chosen dose of CBD as an antipsychotic for people with PDP.
    (ii) To examine whether there is any evidence of drug-drug interaction with the chosen dose of CBD in people with PDP.



    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    NEUROIMAGING MECHANISTIC SUB-STUDY (included as an Addendum to main protocol, version 1.0)


    Objective:
    To investigate the neurophysiological mechanisms underlying the antipsychotic effects of CBD in PDP.
    Mechanistic Efficacy Parameters/Outcome Measures:

    -Within-subject change (pre-treatment minus 6-week post-treatment) in medial temporal, prefrontal, and striatal activation (as estimated from the blood oxygen level-dependent haemodynamic response signal measured using fMRI; BOLD signal) in the MRI scanner.
    -Within-subject change (pre-treatment minus 6-week post-treatment) in functional connectivity between the medial temporal, prefrontal, striatal and visual cortical regions of interest (as estimated from the BOLD signal) and between these regions and the rest of the brain using both resting state and task-based fMRI data in the MRI scanner.


    E.3Principal inclusion criteria
    1. Satisfy established diagnostic criteria (NINDS-NIMH criteria for the diagnosis of Parkinson’s disease psychosis) and UK Brian Bank criteria for idiopathic Parkinson’s disease.
    2. Age 40 or older.
    3. For psychotic symptoms, they should have developed after the PD diagnosis and should have been present for at least 1 month, occurring at least weekly over the month before screening and should have a combined score of at least 6 or an individual score of at least 4 on the neuropsychiatric inventory (NPI) A (delusions) and/or B (hallucinations) subscale in the month before screening.
    4. Parkinson’s disease dementia would not be an exclusion criterion.
    5. Participants with score greater than 18 on the Montreal Cognitive Assessment scale.
    6. TAU will include patients on quetiapine and/ or cholinesterase inhibitors (rivastigmine/ donepezil) as well as standard antiparkinsonian treatments with dosage stable for at least 1 month.
    7. At least 6 months post stereotaxic surgery (deep brain stimulation) and stimulator settings stable for at least 1 month prior to baseline and must remain stable during the trial.
    8. Ability to participate in study evaluation and ingest oral medication.
    9. Reliable informant/caregiver.
    10. Written informed consent to participate.
    E.4Principal exclusion criteria
    1. Insufficient understanding of trial.
    2. History of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson’s disease including, but not limited to, schizophrenia or bipolar disorder.
    3. Psychotic symptoms secondary to other toxic or metabolic disorders.
    4. Psychosis onset after ablative stereotaxic surgery.
    5. Diagnosis of dementia made concurrent with or prior to a PD diagnosis.
    6. Patients on clozapine due to the requirement of special safety monitoring required for clozapine, which will unblind the safety.
    7. Patients taking part in another intervention trial concurrently. However, those withdrawn from another study or who have recently completed another intervention study will be eligible for inclusion if they satisfy study inclusion/ exclusion criteria. For pharmacological intervention, they will be eligible only after a sufficient period of washout (~ 5 times half-life of other study drug).
    8. Participant no longer able to report symptoms as a result of cognitive impairment.
    9. Presence of depressive symptoms would not be an exclusion criterion. However, we would exclude those participants who may have severe depression.
    10. Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behaviour) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
    11. Any medical or psychological condition or social circumstances which may impair their ability to participate reliably in the study, or who may increase the risk to themselves or others by participating in the study.
    12. Significant ocular pathology.
    13. Concomitant medication that has a clinically relevant interaction with the CYP2C19 or CYP3A classes of liver enzymes will not be permitted from two weeks before inclusion until the end of the study. Examples of co-medication that will be not allowed will include CYP3A4 inhibitors (such as itraconazole, ketoconazole, posaconazole, fluconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, telaprevir, boceprevir, imatinib, ticagrelor, voriconazole), CYP3A4 inducers (such as carbamazepine, efavirenz, nevirapin, etravirin) and CYP2C19 inhibitors (such as moclobemine, fluvoxamine, chloramphenicol, fluoxetine).
    14. Female patients who are pregnant or lactating
    15. Female patients of childbearing potential who are not willing to use a highly effective method of contraception for the duration of the trial to prevent pregnancy, or abstain from heterosexual activity.
    *Females of child bearing potential are females who have experienced menarche and are not surgically sterilised (e.g. by hysterectomy, bilateral salpingectomy) or post-menopausal (defined as at least 1 year since last regular menstrual period).

    ** Highly effective methods of birth control are those with a failure rate of < 1% per year when employed consistently and correctly, e.g.
    • combined (oestrogen and progestogen containing) hormonal contraception
    associated with inhibition of ovulation:
    o oral
    o intravaginal
    o transdermal
    • progestogen-only hormonal contraception associated with inhibition of ovulation 1:
    o oral
    o injectable
    o implantable 2
    • intrauterine device (IUD)
    • intrauterine hormone-releasing system ( IUS)
    • vasectomised partner

    Sexual abstinence is considered to be highly effective method only if defined as refraining from heterosexual activity from the date of consent until end of treatment and for 2 weeks after. The reliability of this method should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
    16. Known hypersensitivity to CBD, gelatine or micro-crystalline cellulose.
    17. Mechanistic sub-study only: Patients who have any contraindications to MRI, including: pacemakers, metallic foreign body in the eye, aneurysm clip in their brain, severe claustrophobia where patients would not be able to tolerate the scan etc
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: We will report the maximum tolerated dose of CBD.

    Phase II:
    Safety/ Tolerability Outcomes: Change in safety and tolerability measures (listed below) (frequency or mean value, as appropriate) at the end of week 12 compared to baseline (pre-treatment) for each intervention arm.

    Feasibility Outcomes:
    (i) Percentage of patients recruited and followed up over the time-frame of the study
    (ii) Percentage of patients compliant (*adherence) with treatment by the end of 12-weeks.
    (iii) Retention rate (measured by drop-out) by the end of 12-week treatment.
    *Adherence is defined as at least 50% of the dose taken, measured by pill count.

    Tolerability measures: Review of Adverse Events (AE), Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs) and Serious Unexpected Adverse Reactions (SUSARS) UKU side-effect rating scale for psychotropic drugs

    Safety parameters: Clinical laboratory measures: Haematology (Haemoglobin, Red blood cell count, Platelet count, white blood cell count and differential count), Clinical chemistry (Sodium, Potassium, Creatinine, Urea); Glucose; Liver function test (Total bilirubin, Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline phosphatase); cholesterol (total, LDL, HDL); T3, T4 and thyroid stimulating hormone; Vital signs: Heart rate and Blood pressure; Physical examination; Electrocardiogram (ECG)- 12 lead ECG
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the last visit of the final patient for each of the phases is complete
    E.5.2Secondary end point(s)
    Phase I:
    At each CBD dose employed, we will describe-
    (i) the frequency of dose-limiting toxicities per dose, over the 6-week period of treatment;
    (ii) the change in safety and tolerability measures (frequency or mean value, as appropriate) at the end of week 6 compared to baseline (pre-treatment).
    (iii) the change in CBD and quetiapine and its metabolite and/ or donepezil levels in blood at week 6 compared to baseline (pre-treatment).
    (iv) the change in mean score at week 6 compared to baseline (pre-treatment) and 95% confidence intervals for measures of drug activity (pharmacodynamic signal)
    (v) Percentage of patients compliant (*adherence) with treatment by the end of 6-weeks.
    (vi) Retention rate (measure by drop-out) by the end of 6-week treatment and missing data.
    *Adherence is defined as at least 50% of the dose taken, measured by pill count.

    Phase II:
    (i) Change in mean score on SAPS-PD at week 12 compared to baseline (pre-treatment)
    (ii) Change in mean score on NPI-Q at week 12 compared to baseline (pre-treatment)
    (iii) Change in mean score on SAPS-PD (delusion and hallucination subscales) at week 12 compared to baseline (pre-treatment)
    (iv) Change in cannabidiol and quetiapine and its metabolite and/ or donepezil levels in blood at week 12 compared to baseline (pre-treatment).
    (v) Change in score on United PD rating scale at week 12 compared to baseline (pre-treatment)
    (vi) Change in score on Non-motor symptoms scale at week 12 compared to baseline (pre-treatment)
    (vii) Change in score on Montreal Cognitive assessment scale at week 12 compared to baseline (pre-treatment)
    (viii) Change in score on PDQ-39 scale at week 12 compared to baseline (pre-treatment)
    (ix) Change in score on CGIC scale at week 12 compared to baseline (pre-treatment)
    (x) Change in score on SCOPA-COG scale at week 12 compared to baseline (pre-treatment)
    (xi) Change in score on SCOPA-SLEEP scale at week 12 compared to baseline (pre-treatment)
    (xii) Change in score on Zarit Caregiver burden scale at week 12 compared to baseline (pre-treatment)



    E.5.2.1Timepoint(s) of evaluation of this end point
    at 6 weeks and 12 weeks for part 1 and part 2 respectively
    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 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 No
    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 trial2
    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 concerned4
    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
    The end of the trial will be defined as database lock.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Some of the participants may not have capacity to give informed consent. In such cases, consent will be sought from their legal representative/nearest relative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state144
    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)
    No arrangements are being made for continued access for the study participant to receive CBD after the trial . Once the participant has been discontinued from the study, the participant’s GP will continue to manage them according to the routine standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-20
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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