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    Summary
    EudraCT Number:2012-001548-23
    Sponsor's Protocol Code Number:20124444
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-30
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-001548-23
    A.3Full title of the trial
    An open label study with objective sleepregistration on the effects of Doxazosin as treatment for PTSD, especially for sleep disturbance
    Een open label studie met objectieve slaapregistratie naar het effect van doxazosine op de behandeling voor pttss, met name op slaapstoornissen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Doxazosin for PTSD With sleepregistration (DoPS).
    Doxazosine voor PTSS met slaapregistratie (DoPS)
    A.3.2Name or abbreviated title of the trial where available
    DoPS
    DoPS
    A.4.1Sponsor's protocol code number20124444
    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 SponsorParnassiaBavoGroup
    B.1.3.4CountryNetherlands
    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 supportParnassiaBavoGroup
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationParnassiaBavoGroup
    B.5.2Functional name of contact pointJoop de Jong
    B.5.3 Address:
    B.5.3.1Street AddressCarel Reinierszkade 197
    B.5.3.2Town/ cityDen Haag
    B.5.3.3Post code2593 HR
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31883573006
    B.5.5Fax number31883584207
    B.5.6E-mailj.dejong@psyq.nl
    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 Yes
    D.2.1.1.2Name of the Marketing Authorisation holderDutch: College ter Beoordeling van Geneesmiddelen. English: Medicines Evaluation Board
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDoxazosin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Posttraumatic stress disorder
    posttraumatische stress stoornis
    E.1.1.1Medical condition in easily understood language
    Posttraumatic Stress disorder.
    posttraumatische stress stoornis
    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
    Objective: The purpose of this study is to evaluate the effect on sleep and ptsd of the drug doxazosin in patients with PTSD who also have sleep problems.
    Het doel van het onderzoek is om het effect op slaap en ptss te evalueren tijdens het gebruik van doxazosine bij patienten met ptss en slaapstoornissen.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Good speaking and writing in Dutch
    - PDS above 18
    - CAPS recurrent distressing dreams item score above 5
    - CAPS difficulty falling or staying asleep item above 5
    - No medication except contraceptives or analgetics like paracetamol
    - No alcohol more than two consumptions a day
    - Medication use of psychotropics has stopped at least one month before entrance of the study
    - If psychotherapy has not been started yet it will not be initiated during the trial; If started it will be paused for the period of the study. Medication with influence on sleep-EEG will not be started during the study period (paracetamol and contraceptives are allowed).
    - Goed Nederlands kunnen spreken en schrijven
    - PDS score > 18
    - KIP score (Nederlandse versie van CAPS) op item terugkerende angstaanjagende dromen score meer dan 5
    - Geen medicatiegebruik behalve anti-conceptie of analgetica zoals paracetamol
    - Geen alcoholgebruik boven de twee consumpties per dag
    - Psychofarmaca tenminste 1 maand voor start van onderzoek gestaakt of nooit gestart.
    - Wanneer psychotherapie nog niet begonnen is wordt het gedurende de studie ook niet begonnen en als er wel psychtherapie gegeven wordt zal het gedurende de duur van de studie en de periode van een maand er voor net meer gegeven wordenen zal de psychotherapeut hoogstens enkele steunende gesprekken voeren. Ook andere medicatie met eventuele invloed op slaap-EEG zal niet gestart worden (paracetamol en anti-conceptiva mogen wel).
    E.4Principal exclusion criteria
    Psychiatric:
    - Lifetime schizophrenia,
    - schizoaffective disorder,
    - bipolar disorder,
    - severe depressive disorder (MADRS > 34) (for screening: QIDS > 15)
    - cognitive disorder,
    - current delirium,
    - substance use within 2 months of the study; alcohol is allowed if not more than 2 consumptions a day.
    - severe psychiatric instability (including evidence of being actively suicidal or homicidal).
    - any behavior which poses an immediate danger to patient or others.

    Somatic:
    - preexisting hypotension or (anamnestic) orthostatic hypotension
    - hypertension unless stable with help of anti-hypertensive medication.
    - Known for severe ischaemic heart disease
    - disease with strong reduced functioning of the liver.
    - Women of childbearing potential with either positive pregnancy test or refusal to use effective birth control method.
    - Allergy or previous adverse reaction to doxazosin or other alpha-1 antagonist.
    - Hypersensitivity to quinazolinderivates
    - Known for hypertrophy of the prostate without treatment.
    - Gastro-intestinal obstruction
    - oesophageal obstruction
    - overflow bladder or anuria with or without progressive renal insufficiency
    Psychiatrisch:
    - Schizophrenie ooit in leven,
    - schizoaffective stoornis,
    - bipolaire stoornis,
    - ernstige depressieve stoornis (MADRS > 34) (voor screening: QIDS > 15)
    - cognitieve stoornis,
    - huidig delier.
    - afhankelijkheid van middelen de laatste 2 maanden voor de studie; alcoholgebruik mag als niet meer dan 2 consumpties per dag.
    - ernstige psychiatrische instabiliteit (inclusief aanwijzingen voor actieve suicidaliteit of homicidaliteit).
    - Elk gedrag dat gevaar kan opleveren voor de patient of voor anderen.

    Somatisch:
    - al bestaande hypotensie of (anamnestisch) orthostatische hypotensie
    - hypertensie tenzij stabiel met behulp van anti-hypertensiva.
    - Bekend met ernstig ischaemische hartafwijking.
    - ziekte waarbij sterk beperkt functioneren van de lever.
    - Vrouwen in vruchtbare periode met een positieve zwangerschapstest of weigering om effectieve vormen van anti-conceptie toe te passen.
    - Allergie voor of een eerdere allergische reactie op doxazosiney of een andere alpha-1 antagonist.
    - Overgevoeligheid voor quinazolinderivaten
    - Bekend met hypertrofie van de prostaat zonder behandeling daarvoor.
    - Gastro-intestinal obstructie
    - Slokdarmobstrucite.
    - overflow-blaas or anurie met of zonder progressieve nierinsufficientie.
    E.5 End points
    E.5.1Primary end point(s)
    Main study parameters/endpoints: Primary outcome:
    De primaire parameters zijn
    E.5.1.1Timepoint(s) of evaluation of this end point
    at baseline measurements will be done; as well as during placebo-run-in period, during use of 4 mg doxazosin a day and using "best dosage" (4 or 8 mig a day).
    Startmetingen worden uitgevoerd en tijdens de placebo-run-in periode, gedurende gebruik van 4 mg doxazosin per dag en gedurende de periode van gebruik van de beste dosering (4 of 8 mg per dag).
    E.5.2Secondary end point(s)
    Secondary outcome: total score on CAPS and CAPS subscale score (Reexperiencing/ Intrusions, Avoidance/Numbing and Hyperarousal), score on PTSD Diagnostic Scale (PDS), on.Montgomery-Asberg Depression Scale (MADRS), Clinical Global Impression of Change (CGIC), dissociative experiences scale (DES) and Clinician-Administered Dissociative States Scale (CADDS), psychotic symptoms with help of The Community Assessment of Psychic Experiences (CAPE), Sleep 50 and pulse / Blood- pressure.
    Secundaire onderzoeksvariabelen zijn de totaalscore op de KIP en de KIP subschalen (herbeleving/intrusie, vermijding/ onverschillig zijn, hyperarousal -verhoogde alertheid en prikkelbaarheid) en de score op de PTSD Diagnostic Scale (PDS). Daarnaast worden als onderzoeksvariabelen de Montgomery-Asberg Depression Scale (MADRS), dissociative experiences scale (DES), Clinician-Administered Dissociative States Scale (CADDS), de psychotische symptomen met behulp van de Community Assessment of Psychic Experiences (CAPE), Sleep 50, Clinical Global Impression of Change (CGI - C) enkele malen gedurende de studie afgenomen en wordt pols en bloeddruk regelmatig gemeten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at baseline measurements will be done; as well as during placebo-run-in period, during use of 4 mg doxazosin a day and using "best dosage" (4 or 8 mig a day).
    Startmetingen worden uitgevoerd en tijdens de placebo-run-in periode, gedurende gebruik van 4 mg doxazosin per dag en gedurende de periode van gebruik van de beste dosering (4 of 8 mg per dag).
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    de studie eindigt bij laatste visite door de laatste proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    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: 20
    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 state20
    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; the patients will be asked to give permission to approach them with a possible later research proposal. Before they wll be asked the medical ethical commitees will be asked to agree on the new proposal.
    Nee, de patienten zullen toestemming gevraagd worden om eventueel opnieuw benaderd te worden na het onderzoek met een voorstel voor vervolgonderzoek. Voordat zij benaderd worden zal eerst de medisch ethische commissie gevraagd worden om dat nieuwe voorstel te beoordelen en goed te keuren.
    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 Decision2012-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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