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    Summary
    EudraCT Number:2005-005708-17
    Sponsor's Protocol Code Number:ELB139202-05
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-01-18
    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 number2005-005708-17
    A.3Full title of the trial
    International, multicenter, randomized, double-blind, placebo controlled, two-period, cross-over study to demonstrate safety, tolerability and anxiolytic effects of 600 mg ELB139 given orally t.i.d. to patients with concurrent panic disorder, challenged by inhalation of 35% CO2 after a single dose and one week of treatment
    A.3.2Name or abbreviated title of the trial where available
    ELB139 Proof of concept study in panic disorder
    A.4.1Sponsor's protocol code numberELB139202-05
    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 Sponsorelbion AG
    B.1.3.4CountryGermany
    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 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 Information not present in EudraCT
    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 nameELB139
    D.3.2Product code ELB139
    D.3.4Pharmaceutical form Capsule*
    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.3.8INN - Proposed INNnot yet assigned
    D.3.9.1CAS number 188116-08-7
    D.3.9.2Current sponsor codeELB139
    D.3.9.3Other descriptive nameE131-00139; AWD131-139; A04293
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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*
    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
    Male and female patients with diagnosis of concurrent panic disorder according to DSM-IV, with or without agoraphobia (DSM IV 300.21 and 300.1) according to Mini International Neuropsychiatric Interview (MINI); structured diagnostic psychiatric interview for DSM-IV with at least 2 panic attacks in the last 4 weeks before screening
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10037175
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is to demonstrate that 600 mg ELB139 given orally is effective in reducing subjective anxiety evoked by inhalation of 35% CO2 after the first dose and after approximately one week of t.i.d. treatment as compared to placebo treatment in patients with panic disorder.
    E.2.2Secondary objectives of the trial
    - To investigate treatment effects on typical symptoms of panic disorder other than anxiety, the treatment effects on the reduction of panic attacks according to two definitions as well as the overall severity and change of disease status will also be evaluated.
    - To investigate the safety and tolerability of ELB139
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Diagnosis of concurrent panic disorder according to DSM-IV, with or without agoraphobia (DSM IV 300.21 and 300.1) according to Mini International Neuropsychiatric Interview (MINI); structured diagnostic psychiatric interview for DSM-IV.
    2. At least 2 panic attacks within the 4 weeks before the screening visit.
    3. Naïve to the CO2 challenge test.
    4. Age 18–65 years (inclusive).
    5. Ability to comply with all procedures mandated by the study protocol.
    6. Written informed consent to participate in study.
    7. Negative pregnancy test and agreement to use a highly effective method of birth control for at least three months prior to inclusion in this study and not nursing, if female and with childbearing potential.
    Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomises partner.
    E.4Principal exclusion criteria
    1. History of poly-pharmacotherapy for panic disorder* or treatment resistance**.
    (* More than two different types of psychotropic treatments or two medications given concomitantly against panic disorder)
    (** No response to two well conducted i.e. with a sufficient dose for a sufficient time treatments).
    2. Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia.
    3. Patients in stable remission of panic disorder, i.e. well contralled clinical conditions
    4. History of abuse (according to DSM-IV criteria) of benzodiazepines or tolerance to effects of benzodiazepine.
    5. Any concomitant psychotropic medication (for wash out periods, see Section 7.5)
    6. Known hypersensitivity to any of the drug substances or excipients of the study medication.
    7. Evidence of impaired hepatic (alanin aminotransferase > 3 x upper limit of normal range, gamma glutamyl transferase > 3 x upper limit of normal range, cholinesterase 0,75 x below lower limit of normal range ) or renal function (serum creatinine > 2 x upper limit of normal range).
    8. History or evidence of relevant cardiovascular or cerebrovascular disorders such as angina pectoris, cardiac infarction, cardiomyopathy, cardiac failure, cardiac arrhythmias, TIAs, cerebrovascular accidents.
    9. ECG signs of prolonged cardiac repolarization (QTc value [Bazett's correction] > 450 msec).
    10. Need of concomitant medication with torsadogenic potential (lists 1 and 2 on the web site www.torsades.org) and Appendix 4 of study protocol)
    11. Arterial hypertension with systolic pressure > 180 mmHg or diastolic pressure > 100 mm despite therapy.
    12. History or family history of cerebral aneurysm.
    13. History of epilepsy or recurrent seizures.
    14. History or evidence of clinically relevant respiratory diseases such as asthma, COPD, lung fibrosis.
    15. Family history of sudden unexpected death and/or arrhytmias in family members of age < 45 or presence of familial long QT-syndrome.
    16. Heavy smoker (> 15 cigarettes/day).
    17. Participation in any drug trial in the preceding 6 months.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are the degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety (ranging from 0 to 100) (VAS-A) assessed immediately after the CO2-challenge (VAS-A-post) after a single dose and one week of treatment, and the difference of the degree of anxiety measured as the difference between the pre- and post challenge scores on the Visual Analogue Scale for Anxiety (VAS-A-delta).
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    single-blind placebo run-in and placebo wash-out phases
    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 No
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 this study is defined as the last visit of the last enrolled patient.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.3.3.6.1Details of subjects incapable of giving consent
    Negative pregnancy test and adequate contraceptive measures (if not surgically sterilized or with sterilized partner), such as birth control pill, IUDs or barrier methods for at least three months prior to inclusion in this study and not nursing.
    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 24
    F.4.2.2In the whole clinical trial 24
    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 Decision2006-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2006-08-28
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