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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-001529-18
    Sponsor's Protocol Code Number:LGN-VN-003
    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:2015-06-25
    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 number2015-001529-18
    A.3Full title of the trial
    RESTORE SR: A multi-center, Randomized, double-blind, placebo-controlled study to Evaluate the Safety and efficacy of a single oral dose of vanoxerine for The conversion Of subjects with REcent onset atrial fibrillation or flutter to normal Sinus Rhythm
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to establish the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent onset atrial fibrillation or flutter to normal sinus rhythm
    A.3.2Name or abbreviated title of the trial where available
    RESTORE SR
    A.4.1Sponsor's protocol code numberLGN-VN-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02454283
    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 SponsorLaguna Pharmaceuticals, 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 supportLaguna Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaguna Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street Address4225 Executive Square, Suite 960
    B.5.3.2Town/ cityLa Jolla
    B.5.3.3Post codeCA 92037
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1408813-9981
    B.5.5Fax number+1858939-1942
    B.5.6E-mailJIwashita@lagunarx.com
    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 nameVanoxerine HCl, 200 mg
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNVANOXERINE
    D.3.9.1CAS number 67469-69-6
    D.3.9.4EV Substance CodeSUB00023MIG
    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) 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
    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
    Recent atrial fibrillation (AF) or atrial flutter (AFL)
    E.1.1.1Medical condition in easily understood language
    Recent atrial fibrillation (AF) or atrial flutter (AFL)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    To evaluate the safety and efficacy of a single oral dose of vanoxerine HCl compared to placebo in subjects with AF/AFL for conversion to sinus rhythm.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has been informed of the investigational nature of this study and has given written, informed consent in accordance with institutional, local, and national guidelines.
    2. Able to return for Day 8 follow up and provides at least two modes of contact information (e.g., home and mobile phone numbers, address) and contact information for at least one close contact (e.g., family member or friend) to facilitate Day 30 vital status follow up.
    3. Male or female 18 years of age or greater.
    4. Onset of AF/AFL within the 7 calendar days preceding randomization, based on symptoms.
    5. AF/AFL documented by ECG during the screening period. Subjects with (a) both AF and AFL or (b) coarse fibrillation that is difficult to discern from AFL will be designated as AF. AF or AFL must be reconfirmed electrocardiographically e.g., bedside monitor, telemetry, paper ECG, etc., immediately (within 5 minutes) prior to study drug administration. Subjects who spontaneously convert to sinus rhythm after randomization but before study drug administration will not receive study drug and will not proceed further in the study.
    6. Adherence to local clinical standards or the ACC/AHA or ESC practice guidelines for AF/AFL regarding thromboembolic event prevention and treatment.
    E.4Principal exclusion criteria
    1. Previous exposure to vanoxerine HCl.
    2. Women of childbearing potential (neither surgically sterilized nor post-menopausal defined as cessation of menses for over one year).
    3. Systolic blood pressure <110 mmHg during screening (unless documented to be usual value).
    4. Average heart rate <60 bpm documented by screening ECG.
    5. Average QTc >440 msec documented by screening ECG.
    6. QRS interval >140 msec documented by screening ECG.
    7. Paced atrial rhythm on screening ECG.
    8. Serum potassium <4.0 mEq/L or mmol/L by local laboratory at screening.
    9. Serum magnesium < 1.6 mEq/L or mmol/L or 1.8 mg/dL by local laboratory at screening.
    10. History of receiving another Class I or Class III antiarrhythmic drug within 3 days prior to randomization. Excluded Class I antiarrhythmic drugs include quinidine, procainamide, disopyramide, lignocaine, mexilitine, flecainide, and propafenone. Excluded Class III drugs include, dofetilide, sotalol, dronedarone, and ranolazine.
    11. History of amiodarone (oral or IV) within the 90 days prior to randomization.
    12. Native or prosthetic aortic or mitral stenosis with aortic valve area ≤ 1.0 cm2 or mitral valve area of <1.5 cm2 or any other valvular disease for which surgery is indicated.
    13. Treatment with any loop diuretic (e.g., furosemide, bumetanide, torsemide, ethacrynic acid, etc.) in the 30 days prior to randomization.
    14. Ejection fraction of <35% within the 3 months prior to randomization (most recent measure if more than one).
    15. AF/AFL as a result of surgery (postoperative AF/AFL) within 30 days prior to randomization.
    16. History of electrical cardioversion within the 7 calendar days prior to randomization.
    17. History of any polymorphic ventricular tachycardia including torsades de pointes.
    18. History or family history of long QT syndrome or other inherited arrhythmia syndrome.
    19. History of ventricular tachycardia requiring drug or device therapy.
    20. Participation in another investigational drug or device trial within 30 days prior to randomization. (Subjects in registries may participate with approval of registry sponsor.)
    21. Acute cardiovascular events (myocardial infarction, pulmonary embolism, cerebrovascular accident, unstable angina, or transient ischemic attack) within the 90 days prior to randomization.
    22. Psychiatric disorder, active alcohol/drug abuse, or other circumstance or condition that, in the investigator’s opinion, may interfere with any aspect of protocol adherence (including Day 8 visit or Day 30 follow-up) or a subject’s ability to give informed consent.
    23. Untreated hyperthyroidism
    24. Acute pericarditis
    25. Any unrelated illness (e.g., substantial infection, fever > 37.8 ď‚°Celsius or prescribed antibiotics in the last 7 days, inflammation, acute rheumatic fever, metastatic cancer, severe hepatic impairment, or other medical conditions or laboratory abnormalities), which, in the judgment of the investigator would significantly jeopardize subject’s clinical status.
    26. Receipt of potent CYP3A4 inhibitors within 5 half-lives prior to randomization. Potent CYP3A4 inhibitors include but are not limited to boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazadone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole.
    E.5 End points
    E.5.1Primary end point(s)
    • Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours
    E.5.2Secondary end point(s)
    • Length of Stay (from time of study drug administration)
    • Sinus rhythm present at 12 and 24 hours from study drug administration and at the Day 8 visit.
    • Time to restoration of sinus rhythm through 24 hours.
    • Change in subject symptom score from baseline to 4 and 24 hours from study drug administration and to Day 8.
    Safety endpoint will comprise the occurrence of any of the following events:
    a. Death through Day 8.
    b. Ventricular fibrillation on ECG through 32 hours.
    c. Ventricular tachycardia with heart rate >120 bpm requiring intervention through 32 hours.
    d. Torsades de pointes >10 seconds on ECG through 32 hours. (All episodes of torsades de pointes will be reported [including duration] as a safety variable. Only torsades de pointes >10 seconds will be included as a primary safety outcome endpoint.)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Length of Stay: 8 days
    Sinus rhythm: 12 and 24 hours
    Time to restoration of sinus rhythm: 24 hours
    Change in subject symptom score : 4 hours, 24 hours, Day 8

    Death: Day 8
    Ventricular fibrillation: 32 hours
    Ventricular tachycardia: 32 hours
    Torsades de pointes: 32 hours
    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 Yes
    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) 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 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.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Bulgaria
    Czech Republic
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Poland
    Romania
    Russian Federation
    United States
    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
    Last Visit Last Subject (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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.1.2.1Number of subjects for this age range: 156
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 469
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 557
    F.4.2.2In the whole clinical trial 625
    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 will continue to receive standard of care treatment.
    If a subject withdraws from study, it is recommended that elective treatment with Vaughn-Williams Class I and III antiarrhythmic medications not be started until 32 hours after study drug administration.
    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 Decision2015-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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