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    Summary
    EudraCT Number:2006-002477-45
    Sponsor's Protocol Code Number:ERX_01_05
    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:2006-11-13
    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 number2006-002477-45
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter evaluation of the efficacy and safety of terguride tablets, administered orally for 3 months,
    to patients with fibromyalgia.
    A.4.1Sponsor's protocol code numberERX_01_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 SponsorErgoNex Pharma GmbH
    B.1.3.4CountrySwitzerland
    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 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 nameTerguride 0.5 mg tablet
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNTerguride
    D.3.9.1CAS number 37686-84-3
    D.3.9.3Other descriptive nameTransdihydrolisuride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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 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 placeboTablet
    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
    fibromyalgia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10048439
    E.1.2Term Fibromyalgia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority of terguride 3 mg/d over placebo in the 12 week treatment of fibromyalgia associated pain on the visual analogue scale (VAS) called "Schmerzskala" from Mundipharma.
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of terguride in patients suffering from fibromyalgia.
    To assess the influence of terguride on:
    · Fibromyalgia Impact Questionnaire (FIQ-G),
    · Tender Point Score (TPS),
    · Hamilton Depression Scale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients (m or f) are eligible for the study when they fulfil the following criteria:
    ·Diagnosis of fibromyalgia according to ACR criteria (1990) [Wolfe et al. 1990]
    ·Pain score ³50 mm on the patient pain VAS (100 mm)
    ·Tender point Score (TPS) ³ 11
    ·Age range from 18 to 60 y (inclusive)
    ·Body Mass Index (BMI): 18.9 < BMI < 30.0
    ·A written informed consent to participate in this study signed by the subject prior to initiation of any study specific procedure
    ·Treatment as outpatients
    E.4Principal exclusion criteria
    A patient fulfilling the following exclusion criteria must not enter the study:
    · known sensitivity to study drug
    · suffering from relevant liver (limit for GOT and GPT: < 3-fold of upper limit of NR), kidney (limit for serum creatinine: < 1.5 mg/dL), cardiovascular (i.e. heart attack or cerebrovascular disease) or pulmonary disease (i.e. asthma or COPD)
    · suffering from pituitary tumor representing extrasellar expansion
    · suffering from peptic ulcers or having a history of it
    · suffering from Raynaud syndrome or having a history of it
    · suffering from psychosis or having a history of it
    · suffering from a systolic blood pressure ³140 mm Hg and a diastolic pressure ³ 90 mm Hg. (Criteria in accordance with the 7th report of the joint national committee on prevention, detection, evaluation and treatment of high blood pressure (NIH Publication # 04-5230 (2004))
    · suffering from Encephalomyelitis disseminata
    · suffering from chronic inflammatory diseases
    · evidence or history of drug or alcohol abuse
    · mental impairment limiting the ability to comply with study requirements
    · receiving therapy with agents known or likely to interact with study drug or disease:
    - Antidepressants or SSRIs are not allowed from 6 weeks before V(-1) throughout the entire study. However, patients with substantial therapeutic benefit from such compounds should not be discontinued for study participation.
    - Antiepileptics, Anxiolytics, Muscle relaxants or Hypnotics have to be discontinued at least 10 elimination half lives of the respective drug before V(-1); for details see section 9.4.7,
    · participation in any clinical study or donation of blood in the period from 60 days prior to study initiation until end of study .
    Additionally, women with child bearing potential must be excluded if:
    · They have not used reliable contraception in the cycle before the study. According to CPMP/ICH/286/95 (modification) highly effective methods of birth control (defined by a failure rate < 1% per year) include the consistent and correct use of implants, injectables combined oral contraceptives, selected intrauterine devices (IUD), sexual abstinence or vasectomised partner The subject has to agree to continue using such highly reliable contraception during the entire study period and the cycle after the study
    · They are pregnant or lactating. (A negative pregnancy test must be provided for all female subjects with child bearing potential at screening and on Day 0)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the pain intensity given by the patient on the VAS (0 100 mm) called "Schmerzskala" from Mundipharma. The absolute and relative (%) change from baseline (V0) to V12 will be calculated for each patient.
    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 concerned10
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the trial is defined as the 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 years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 72
    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 Decision2007-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-28
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