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    Summary
    EudraCT Number:2010-019369-27
    Sponsor's Protocol Code Number:ANX001-01
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-09
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-019369-27
    A.3Full title of the trial
    A Phase II randomized, double-blind, parallel-group, multi-site, placebo controlled fixed-dose study of Echinaceae angustifoliae root dry extract in 24 outpatients with generalized anxiety disorder (GAD)
    A.4.1Sponsor's protocol code numberANX001-01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAnxiofit Ltd.
    B.1.3.4CountryHungary
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namen/a
    D.3.2Product code ANX001
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 90028-20-9
    D.3.9.3Other descriptive nameEchinacea ang. root dry extract
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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 placeboFilm-coated tablet
    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
    Generalized Anxiety Disorder (GAD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10018075
    E.1.2Term Generalised anxiety disorder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to conduct a preliminary evaluation of the safety and efficacy of the narrow-leaved coneflower root (Echinaceae angustifoliae radix) dry extract as compared to placebo for the treatment of generalized anxiety disorder (GAD) in order to gather data to estimate intervention parameters (i.e to quantify an estimate of possible effect) and to provide an estimate of the variance as this variance may be used in a formal sample size calculation in a subsequent study.
    The context of the justifications for this pilot study is that future study(s) will use the information from it in its/their design.
    E.2.2Secondary objectives of the trial
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) based on a structured Mini-International Neuropsychiatric Interview
    2. Subjects must have a HAM-A total score ≥17 and ≤25 at the screening (V1) and randomization (V2) visits. On items 1 (anxious mode) and 2 (tension) a score of 2 or more will be required.
    3. Subjects must have a total score of ≤10 on Beck scale
    Subject must have a ≥3 point on CGI
    5. Otherwise healthy men or non-pregnant, non-lactating women (women must be using a hormonal or barrier method of contraception or be postmenopausal or surgically sterilized). Healthy is defined as no other clinically relevant abnormalities identified by a detailed medical history, full physical examination including sitting blood pressure (BP) and heart rate measurement.
    6. Age 18 to 60 years, inclusive.
    7. All women must have negative pregnancy tests at the Screening (V1) and Randomization (V2) visits.
    8. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed and understood of all pertinent aspects of the study.
    9. Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
    E.4Principal exclusion criteria
    1.Subjects with evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
    2. Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses:
    o Major depressive disorder;
    o Obsessive compulsive disorder;
    o Panic disorder;
    o Agoraphobia;
    o Posttraumatic stress disorder;
    o Anorexia;
    o Bulimia;
    o Caffeine-induced anxiety disorder;
    o Alcohol or substance abuse or dependence unless in full remission for at least 6 months;
    o Social anxiety disorder
    3. Any of the following past or current DSM-IV Axis I diagnoses:
    o Schizophrenia;
    o Psychotic disorder;
    o Delirium, dementia, amnestic, and other clinically significant cognitive disorders;
    o Bipolar or schizoaffective disorder;
    o Cyclothymic disorder;
    o Dissociative disorders
    Antisocial or borderline personality disorder.
    5. Serious suicidal risk per the clinical investigator's judgment. (Note: The Suicidality module of the MINI diagnostic interview should be used as aid to the assessment of suicidality, but does not replace overall clinical judgment in determination of suicidal risk).
    6. Current use of psychotropic medications (ie, drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 5 weeks of randomization. In the event of inadvertent administration of psychotropic medications during the 2 weeks prior to randomization, continued eligibility will be assessed on a case by case basis by the investigator and the medical monitor.
    7. Use of drugs, supplements, prescription or nonprescription, or food that have psychoactive properties. In the event of inadvertent use of such products during the 2 weeks prior to randomization, continued eligibility will be assessed on a case by case basis by the investigator and the medical monitor.
    8. Subjects who have been treated with monoamine oxidase inhibitors in the 14 days prior to the baseline visit.
    9. Regular use of benzodiazepines during the 3 months prior to Screening (for at least 5 out of 7 days per week).
    10. Subjects initiating formal psychotherapy within 3 month prior to screening who intend to continue formal psychotherapy during the study. This includes psychodynamic, cognitive, and interpersonal therapies.
    11. Positive drug tests at Screening or Randomization visits for any of the following substances or classes of compounds: amphetamines, barbiturates, opiates, benzodiazepines, sedatives and hypnotics, cocaine, phencyclidine (PCP), cannabinoids, or other illegal or illicit drugs.
    12. Any condition possibly affecting drug absorption (eg, gastrectomy).
    13. Subjects with a current seizure disorder.
    14. Subjects with a history of life-threatening neoplasms within 5 years prior to study entry, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.
    15. Subjects with earlier known hypothyroidism or hyperthyroidism, except subjects who are euthyroid and have been on stable doses of thyroid replacement for 6 months or more.
    16. Subjects with any earlier diagnosed and at the time of enrolment clinically unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disorder.
    17. History of allergy or intolerance to any Echinaceae product.
    18. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of the study.
    19. Treatment with an investigational drug within 60 days preceding the first dose of trial medication.
    20. Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with trial participation or investigational product administration or
    may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Detectable differences in the mean changes on the Hamilton Anxiety Scale in Echinacea and Placebo groups
    Secondary efficacy endpoints (only exploratory):
    Proportion of patients not responding to treatment, Proportion of patients with mild response, defined as 25% improvement on the HAM-A scale Proportion of patients with marked response defined as 50% improvement on HAM-A scale Proportion of fully recovered patients defined as decrease on HAM-A scale below 7 point Time to symptom improvement defined as time required for
    25%, 50% improvement or decrease of HAM-A scale below 7 point The mean changes in psychic and somatic subscales of the Hamilton anxiety scales Changes in items 1 and 2 of the Hamilton anxiety scale (i.e. cardinal symptoms of anxiety disorders (anxiety, excessive worry, tension) Mean change from baseline of Clinical Global Impression severity of illness scale (CGI) Mean change from baseline on the anxiety subscale of the patients rated Hospital Anxiety and Depression Scale, its anxiety component only (HADS-A) Mean change from baseline on the Perceived Stress Scale
    Safety endpoints:
    Safety assessments will consist of monitoring and recording all adverse events including serious adverse events, vital signs, physical condition and body weight. The safety endpoints are:
    Incidence of adverse events; Physical examination; Vital signs
    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.8.3 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 concerned5
    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 Information not present in EudraCT
    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
    last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 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.1.3Elderly (>=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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 Decision2010-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-04
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