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    Summary
    EudraCT Number:2007-005701-22
    Sponsor's Protocol Code Number:Droxidopa-303
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-27
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-005701-22
    A.3Full title of the trial
    A MULTI-CENTER, OPEN-LABEL STUDY, WITH A TWO WEEK RANDOMIZED, PLACEBO-CONTROLLED, WITHDRAWAL PERIOD, TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF DROXIDOPA IN SUBJECTS WITH PRIMARY AUTONOMIC FAILURE, DOPAMINE BETA HYDROXYLASE DEFICIENCY OR NON-DIABETIC NEUROPATHY AND SYMPTOMATIC NEUROGENIC ORTHOSTATIC HYPOTENSION
    A.4.1Sponsor's protocol code numberDroxidopa-303
    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 SponsorChelsea Therapeutics Inc
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name DOPS
    D.2.1.1.2Name of the Marketing Authorisation holderDainippon Sumitomo Pharma Co. Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/465;EU/3/07/466
    D.3 Description of the IMP
    D.3.1Product nameDroxidopa
    D.3.4Pharmaceutical form Capsule, hard
    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 INNDROXIDOPA
    D.3.9.1CAS number 23651958
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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.2.1.1.1Trade name DOPS
    D.2.1.1.2Name of the Marketing Authorisation holderDainippon Sumitomo Pharma Co. Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/465;EU/3/07/466
    D.3 Description of the IMP
    D.3.1Product nameDroxidopa
    D.3.4Pharmaceutical form Capsule, hard
    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 INNDROXIDOPA
    D.3.9.1CAS number 23651958
    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 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 placeboCapsule, hard
    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
    Symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic Failure (PD, MSA and PAF), DBH deficiency and Non-Diabetic Neuropathy.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Evaluate the durability of effect of droxidopa as measured by the relative mean change of the Orthostatic Hypotension Questionnaire (OHQ) composite score following a 14 day placebo-controlled, randomized withdrawal period following 3 months of open-label droxidopa treatment.

    Open-label follow up (safety):
    • Evaluate the safety of droxidopa as measured by the occurrence of treatment-emergent adverse events and specific evaluations of blood pressure, heart rate, ECG, and laboratory findings across the study.
    E.2.2Secondary objectives of the trial
    • Evaluate the clinical efficacy of droxidopa as measured by symptom and activity measurements using the scores of OHSA, OHDAS;
    • Evaluate clinical efficacy of droxidopa using the clinician-recorded and patient-recorded Clinical Global Impressions - Severity (CGI-S) and Clinical Global Impressions - Improvement (CGI-I) scales;
    • Follow the clinical efficacy of droxidopa as measured by assessment of blood pressure during orthostatic challenge tests;
    • Evaluate the safety of droxidopa as measured by the occurrence of treatment-emergent adverse events and specific evaluations of blood pressure, heart rate, ECG, and laboratory findings.

    Open-label follow up (safety):
    • Describe long term clinical efficacy of open-label droxidopa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Demonstrated a symptomatic response (an improvement of at least 1 point in Item #1 of the OHSA) to treatment with droxidopa during open-label titration in Droxidopa Protocol 302

    b) Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.
    E.4Principal exclusion criteria
    a) Currently taking vasoconstricting agents such as ephedrine, dihydroergotamine or midodrine;
    - Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their study entry visit (Visit 1).

    b) Currently taking anti-hypertensive medication
    -The use of short-acting anti-hypertensive medications at bedtime is permitted;

    c) Currently taking tri-cyclic antidepressant medication or other norepinephrine reuptake inhibitors;

    d) Have changed dose, frequency and or type of prescribed medication, within two
    weeks of study entry visit (Visit 1) with the following exceptions: vasoconstricting agents such as ephedrine, dihydroergotamine or midodrine; short courses of or other medications/treatments that do not interfere with, or exacerbate the patient's condition under study

    e) History of more than moderate alcohol consumption;

    f) History of known or suspected drug or substance abuse;

    g) Women of childbearing potential who are not using a medically accepted
    contraception;
    • Reproductive potential: Female subjects should be either postmenopausal
    (amenorrhea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) who are using or agree to use acceptable methods of contraception. Acceptable contraceptives include intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
    • For WOCP a urine pregnancy test must be conducted at each study visit.
    WOCP must be advised to use acceptable contraceptives throughout the study
    period and for 30 days after the last dose of investigational product. If hormonal
    contraceptives are used they should be taken according to the package insert. WOCP who are not currently sexually active must agree to use acceptable
    contraception, as defined above, if they decide to become sexually active during
    the period of the study and for 30 days after the last dose of investigational
    product.

    h) Sexually active males whose partner is a WOCP and who do not agree to use
    condoms for the duration of the study and for 30 days after the last dose;

    i) Women who are pregnant or breast feeding;

    j) Known or suspected hypersensitivity to the study medication or any of its
    ingredients;

    k) Pre-existing sustained severe hypertension (BP ≥ 180/110 mmHg in the sitting
    position);

    l) Have atrial fibrillation or, in the investigator’s opinion, have any other significant
    cardiac arrhythmia;

    m) Any other significant systemic, hepatic, cardiac or renal illness;

    n) Diabetes mellitus or insipidus;

    o) Have a history of closed angle glaucoma;

    p) Have a known or suspected malignancy;

    q) Patients with known gastrointestinal illness or other gastrointestinal disorder that
    may, in the investigator’s opinion, affect the absorption of study drug;

    r) In the investigator’s opinion, have clinically significant abnormalities on clinical
    examination or laboratory testing;

    s) In the investigator’s opinion, are unable to adequately co-operate because of
    individual or family situation;

    t) In the investigator’s opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major
    depression, dementia;

    u) Are not able or willing to comply with the study requirements for the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)

    Safety:
    • The occurrence of treatment-emergent adverse events and specific evaluations of blood pressure, heart rate, ECG, and laboratory findings across the study.

    Clinical Efficacy:
    • Mean change in OH symptoms, using the OHQ composite score, between droxidopa and placebo-treated patients (randomized withdrawal portion of study)
    • Symptom and activity measurements using the scores of OHSA, OHDAS;
    • Assessment of blood pressure during orthostatic challenge testing.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    withdrawal design study
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 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) Yes
    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 60
    F.4.2.2In the whole clinical trial 118
    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)
    Patients who complete the 1-year open-label droxidopa treatment period will be offered continued open-label droxidopa through a separate access program
    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 Decision2008-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-05
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