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    Summary
    EudraCT Number:2021-005331-23
    Sponsor's Protocol Code Number:SCOUT-015
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-05-18
    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 ConcernedSweden - MPA
    A.2EudraCT number2021-005331-23
    A.3Full title of the trial
    A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients with Prader-Willi Syndrome
    En randomiserad, dubbelblind, placebo-kontrollerad fas 2/3-studie av RAD011 (oral cannabidiollösning) för behandling av patienter med Prader-Willis syndrom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients with Prader-Willi Syndrome
    A.4.1Sponsor's protocol code numberSCOUT-015
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05098509
    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 SponsorRadius Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRadius Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadius Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address22 Boston Wharf Rd, 7th Floor
    B.5.3.2Town/ cityBoston
    B.5.3.3Post codeBoston, MA 0221
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617551-4700
    B.5.5Fax number+1617551-4701
    B.5.6E-mailSCOUT015@radiuspharm.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 nameRAD011
    D.3.2Product code RAD011
    D.3.4Pharmaceutical form Oral solution in bottle
    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
    D.3.9.1CAS number 13956-29-1
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboOral solution in bottle
    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
    Hyperphagia related behavior associated with Prader-Willi Syndrome
    E.1.1.1Medical condition in easily understood language
    Uncontrollable appetite behavior associated with Prader-Willi Syndrome
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020710
    E.1.2Term Hyperphagia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 2 Part:
    The primary objective of the Phase 2 part of this study is to assess the safety and tolerability of multiple doses levels of RAD011 in order to select 1 or 2 dose level(s) to further evaluate in the Phase 3 part of the study.
    Phase 3 Part:
    The primary objective of the Phase 3 part of this study is to assess the effect of RAD011 on hyperphagia-related behavior in patients with PWS.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the following:
    - Effect of RAD011 on irritability
    - Effect of RAD011 on Clinician Global Impression of Change (CGI-C) in Hyperphagia
    - Effect of RAD011 on Clinician Global Impression of Severity(CGI-S) of Hyperphagia
    - Safety and tolerability of RAD011.

    Other objectives of this study are to assess the following:
    - Effect of RAD011 on Caregiver Global Impression of Change (CaGI-C) in Hyperphagia
    - Effect of RAD011 on Caregiver Global Impression of Severity (CaGI-S) of Hyperphagia
    - Effect of RAD011 on Caregiver Global Impression of Change (CaGI-C) in Irritability
    - Effect of RAD011 on overall behavior
    - Effect of RAD011 on sleep
    - Effect of RAD011 on body mass index (BMI) and weight
    - Effect of RAD011 on skin-picking behavior
    - Effect of RAD011 on total muscle/fat composition (performed at selected US sites).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Presence of a parent/legal guardian that is able to consent for their participation. Parent/caregiver/legal guardian can complete the required assessments throughout the study. Patient consent/assent will be obtained if the patient is 8 years of age or older and has the mental capacity to understand and sign a written consent/assent form and/or give verbal assent
    2. Males and females between:
    a. Phase 2: 12 and 65 years of age (inclusive) at time of consent/assent
    b. Phase 3: 8 and 65 years of age (inclusive) at time of consent/assent
    3. Documentation of genetically confirmed PWS diagnosis
    4. If a caregiver helps in completing the HQ-CT or other questionnaires, the same caregiver is available to complete the questionnaire throughout the duration of the study
    5. If female, is either not of childbearing potential (defined as premenarchal or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing one of the following medically acceptable methods of birth control up to 4 weeks after the last dose of RAD011 or placebo:
    a. Double barrier method (i.e., condom plus occlusive cap (diaphragm or cervical/vault caps), condom or occlusive cap plus spermicide
    b. Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives at a stable dose for a minimum of 1 full cycle (based on the patient’s usual menstrual cycle period) before IP administration
    c. Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
    d. If not using hormonal contraceptives or IUD or IUS, then all male partners throughout the study must have been vasectomized and have received medical assessment of the surgical success
    6. If male, is vasectomized and has received medical assessment of the surgical success or agrees to use an approved method of contraception (double barrier method as described in Inclusion Criterion 5, female partner’s use of an IUD or IUS [in place at least 12 weeks prior to dosing], oral contraceptives or female partner who is surgically sterile or 2 years postmenopausal) and agrees to use this method for 4 weeks after last administration of RAD011 or placebo
    7. If receiving growth hormone (GH), psychotropic therapy, metabolic treatments that could affect appetite (including metformin), and other treatment including thyroid hormone, must be on the same medication and stable dose for at least 90 days prior to consent/assent
    8. Any non-medical interventions (eg, counseling, behavior modification) should be stable for at least 90 days prior to consent/assent
    9. HQ-CT eligibility automatically calculated in the electronic data capture (EDC) system:
    a. Visit 2
    i. Patients with a mean HQ-CT score ≥13 (from Visit 1 and Visit 2) will be eligible to continue in the Tolerability Period
    b. Visit 5
    i. Patients with a mean HQ-CT score ≥13 (from Visit 3, Visit 4 and Visit 5) will be eligible for randomization, and
    ii. Patients with a decrease in HQ-CT score (from Tolerability Period to the Screening Period) ≤7 will be eligible for randomization
    E.4Principal exclusion criteria
    1. Hypersensitivity or intolerance to CBD, or any other excipients used in the RAD011 preparation
    2. Known use of cannabis or cannabinoid containing products (including topical products) within 90 days prior to consent/assent
    3. History of chronic liver disease, such as cirrhosis or chronic hepatitis due to any cause
    4. Positive urine test for drugs of abuse, including tetrahydrocannabinol (THC), or known history of drug, alcohol, or substance abuse
    5. Use of prescription or over-the-counter weight loss agents within 90 days prior to consent/assent
    6. Implementation of new food restrictions or environmental restrictions within 90 days of consent/assent
    7. Any significant comorbid condition or disease:
    a. Respiratory disease, heart disease, or psychiatric disorder which in the opinion of the Investigator would preclude the patient from participating or
    b. Uncontrolled type 1 or type 2 diabetes as determined by the Investigator or
    c. Clinically significant ECG abnormalities or other evidence of clinically significant heart disease as determined by the Investigator or
    d. Uncontrolled sleep apnea as determined by the Investigator or
    e. Neutropenia with neutrophil counts <1,000 /microL (grade 3 or grade 4 neutropenia as defined by CTCAE v5.0) or
    f. History or presence of gastrointestinal disorders or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs taken orally as determined by the Investigator
    8. QT interval corrected for heart rate (HR) according to Fridericia's formula (QTcF) meeting the following criteria:
    a. For males and females aged 8 to <20 years: QTcF >439 msec
    b. For males aged 20 to 65 years: QTcF >450 msec
    c. For females aged 20 to 65 years; QTcF >470 msec
    9. At consent/assent, patients with age-matched hypertensive levels of systolic and/or diastolic blood pressure may be excluded at the Investigator’s discretion if deemed to be in the best interest of the patient.
    10. Pregnant (determined by a positive serum pregnancy test) or lactating female
    11. Unwillingness or inability to follow the procedures outlined in the protocol
    12. Estimated glomerular filtration rate <30 mL/min/1.73m2 or protein/creatinine ratio ≥0.4
    13. Bilirubin >1.5 × upper limit of normal (ULN), or aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3 × ULN, or international normalized ratio (INR) >1.5 × ULN
    14. Patient judged by the Investigator or Sponsor (or designee) as unable to comply with the treatment protocol, including appropriate supportive care, follow up, and research tests
    15. Other genetic, hormonal, chromosomal, cognitive, or behavioral impairment
    16. If living in a group home, patient spends less than 25 waking hours with their caregiver per week
    17. Significant risk of committing suicide based on history, routine psychiatric examination, or based on the Investigator's judgment
    18. Participation in any other study involving an investigational product or device within 4 weeks or 5 half-lives (whichever is longer) of consent/assent or longer as required by local regulations
    E.5 End points
    E.5.1Primary end point(s)
    - Change in HQ-CT scores from Baseline through End of Study/Week 34 Visit for RAD011 compared to placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline through End of Study/Week 34 Visit
    E.5.2Secondary end point(s)
    - Change in PWS-associated Irritability from Baseline through End of Study/Week 34 Visit using the Aberrant Behavior Checklist (ABC) questionnaire – Irritability subscale (ABC-I) for RAD011 compared to placebo
    - Change in hyperphagia as defined by the Clinician Global Impression of Change (CGI-C) in Hyperphagia through End of Study/Week 34 Visit
    - Change in Clinician Global Impression of Severity (CGI-S) of Hyperphagia Scale from Baseline through End of Study/Week 34 Visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline through End of Study/Week 34 Visit for all secondary endpoints.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 Yes
    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 trial6
    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 EEA10
    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
    Australia
    Canada
    United States
    France
    Sweden
    Spain
    Italy
    Belgium
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 163
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 138
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    - Adult patients unable to decide autonomously
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 220
    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)
    All patients completing the End of Study Visit may be offered enrollment in a long-term extension study. Otherwise, patients will be treated as per standard of care.
    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 Decision2022-07-13
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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