Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44403   clinical trials with a EudraCT protocol, of which   7413   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-002211-25
    Sponsor's Protocol Code Number:THC-PTSD-Trial
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-002211-25
    A.3Full title of the trial
    “Treating Nightmares in Posttraumatic Stress Disorder with Dronabinol: A Randomized Controlled Study (THC PTSD-trial)”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    "Behandlung von Alpträumen bei posttraumatischer Belastungsstörung mit Dronabinol: Eine randomisierte kontrollierte Studie (THC PTSD-Studie)"
    A.3.2Name or abbreviated title of the trial where available
    THC-PTSD-Trial
    A.4.1Sponsor's protocol code numberTHC-PTSD-Trial
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportBionorica SE
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressHindenburgdamm 30
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code12200
    B.5.3.4CountryGermany
    B.5.4Telephone number4930450517545
    B.5.5Fax number4930450517924
    B.5.6E-mailstefan.roepke@charite.de
    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 nameDronabinol
    D.3.2Product code BX-1
    D.3.4Pharmaceutical form Oral solution
    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 INNDRONABINOL
    D.3.9.1CAS number 1972-08-3
    D.3.9.4EV Substance CodeSUB06407MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeTHCV isolate ≥ 95.% with an herbal drug: Cannabis flos, totum as the starting material.
    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
    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
    Posttraumatic Stress Disorder
    E.1.1.1Medical condition in easily understood language
    Posttraumatic Stress Disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective of the study is to examine whether oral dronabinol (2.5 to 15 mg) reduces nightmares to a greater extent than placebo in patients with posttraumatic stress disorder
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are to examine the efficacy of oral dronabinol in reducing other PTSD-specific symptoms, general sleep parameters and depressive symptoms in patients with posttraumatic stress disorder
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of posttraumatic stress disorder (PTSD) according to DSM-5 with a 20 item CAPS-5 total score ≥ 26
    2. At least two nightmares a week, an intensity score ≥ 2, with a CAPS-IV B2 (frequency and intensity for the last week) score ≥ 5
    3. Men and women between 18 and 65 years of age
    4. Written informed consent
    5. The patient has the capacity to give consent (He/she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention)
    6. The patient is not breastfeeding
    7. Women of child-bearing potential must have a negative urine or serum pregnancy test
    8. All participants must use highly effective contraception
    9. The patient received stable pharmacological medication for at least 4 weeks prior to study entry (any changes in medication dose or frequency of therapy must be answered with no)
    E.4Principal exclusion criteria
    1. Lifetime cannabis use disorder
    2. Current substance/alcohol use disorder (≤ 3 months);
    3. Acute suicidality;
    4. Psychotic disorder;
    5. Bipolar disorder;
    6. Current anorexia nervosa;
    7. Current major depressive episodes and a MADRS score > 29;
    8. Dementia;
    9. Trauma-focused psychotherapy four weeks before the trial
    10. Initiation of sleep medication 4 weeks prior screening or initiation of alpha adrenergic agents 4 weeks prior to screening
    11. Acute or unstable medical illness.
    12. Epilepsy
    13. Relevant heart diseases
    14. Known HIV- and/or active Hepatitis-B- or Hepatitis-C-infection
    15. Current or past malignant illness
    16. The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons
    17. Patients, who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
    18. The patient is legally detained in an official institution
    19. The patient does have a known allergy or contraindication against Dronabinol
    20. The patient does have clinically significant abnormalities in 12-lead ECG
    21. The patient does have clinically significant laboratory abnormalities
    22. The patient did participate in other interventional trials during the 3 months before and at the time of this trial
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0–8, directly after last intervention (10 weeks, Visit 8). A lower score indicates less frequent and/or intense nightmares.
    E.5.1.1Timepoint(s) of evaluation of this end point
    CAPS-IV B2 will be evaluated directly after last intervention (10 weeks) at visit 8
    E.5.2Secondary end point(s)
    1. Change from baseline of the frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0–8, at Visit 3 – Visit 7
    2. Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week) at Visit 6 and Visit 8
    3. Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI-A) (PTSD related sleep symptoms) at Visit 2 – Visit 8
    4. Change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS, depressive symptoms) at Visit 6 and Visit 8
    5. Weekly mean of change from baseline of the patients daily total sleep time (in minutes), sleep onset latency at night (in minutes), recuperation of night sleep (5-point Likert scale, 1 = very much; 5 = not at all), and time awake at night (in minutes), number of nightmares last night (0, 1, 3, 4 or more) and intensity of nightmares (5-point Likert scale, 0 = not at all; 5 = extreme) assessed with sleep diaries during Visit 2 – Visit 8
    6. Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5) at Visit 6 and Visit 8
    7. Change from baseline of the Borderline Symptom List 23 (BSL-23) score at Visit 6 and Visit 8
    8. Change from baseline of the Health-Related Quality of Life (EQ-5D) score at Visit 6 and Visit 8
    9. Overall patients status measured by the Patient Global Impression of Change (PGIC) at Visit 6 and Visit 8
    10. Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS) at Visit 6 and Visit 8
    11. Change from baseline of the Pittsburgh Sleep Quality Index (PSQI) at Visit 6 and Visit 8
    12. Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ) at Visit 6 and Visit 8
    13. Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist (MWC) at Visit 6, Visit 8, and Visit 9
    14. Responder analysis: proportion of patients showing improvement in nightmares (change from baseline) defined as decrease of CAPS-IV B2 ≥50% assessed at the end of treatment (Visit 8)
    15. Remitter analysis: proportion of patients showing full remission of nightmares defined as CAPS-IV B2 = 0, assessed at the end of treatment (Visit 8)
    E.5.2.1Timepoint(s) of evaluation of this end point
    CAPS-IV B2 will be evaluated
    at every visit except visit 8 (screening, visit 1 -visit 7)

    CAPS-5 will be evaluated at
    screening (last month version),
    baseline: visit 1 (last week version),
    visit 6 (last week version),
    visit 8 (last week version),

    PSQI A will be evaluated at the end of:
    - Baseline: visit 1 (week 0)
    - visit 2 (week 1)
    - visit 3 (week 2)
    - visit 4 (week3)
    - visit 5 (week 4)
    - visit 6 (week 6)
    - visit 7 (week 8)
    - visit 8 (week 10)

    MADRS will be evaluated at the end of:
    - Screening
    - Baseline: visit 1 (week 0)
    - visit 5
    - visit 8

    For evaluation of sleep-wake time and nightmares: Sleep logs during the entire Trial (visit 1 to visit 9)

    PCL-f, BSL-23, EQ5D, SOFAS, PSQI, ITY, MWC at visit 1, visit 6, visit 8

    PGIC at visit 6 and visit 8
    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 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 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 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 concerned3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    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: 176
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state176
    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)
    Once study THC-PTSD ist finished, patients will continue with their standard of care medication.
    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 Decision2020-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Jul 12 03:18:27 CEST 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA