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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2021-001627-40
    Sponsor's Protocol Code Number:FLE-007
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-10-25
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2021-001627-40
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm
    Randomizované, dvojitě zaslepené, placebem kontrolované hodnocení fáze 3 inhalačního roztoku flekainid acetátu při kardioverzi nově vzniklé symptomatické fibrilace síní na sinusový rytmus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate the efficacy of flecainide acetate inhalation solution on restoring the normal heart rhythm in patients with recent-onset, symptomatic atrial fibrillation.
    A.3.2Name or abbreviated title of the trial where available
    RESTORE-1
    A.4.1Sponsor's protocol code numberFLE-007
    A.5.4Other Identifiers
    Name:IND NumberNumber:147305
    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 SponsorInCarda 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 supportInCarda Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInCarda Therapeutics, Inc.
    B.5.2Functional name of contact pointRESTORE-1 Study Lead
    B.5.3 Address:
    B.5.3.1Street Address39899 Balentine Drive, Suite 185
    B.5.3.2Town/ cityNewark
    B.5.3.3Post codeCA 94560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1510422 5522
    B.5.6E-mailRESTORE-1@incardatherapeutics.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 nameflecainide acetate
    D.3.2Product code FlecIH-103
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFlecainide Acetate
    D.3.9.1CAS number 54143-56-5
    D.3.9.2Current sponsor codeFlecainide Acetate
    D.3.9.3Other descriptive nameFLECAINIDE ACETATE
    D.3.9.4EV Substance CodeSUB13894MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    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 placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recent-onset symptomatic atrial fibrillation
    E.1.1.1Medical condition in easily understood language
    Atrial fibrillation
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of flecainide acetate inhalation solution and placebo for the conversion of atrial fibrillation (AF) to sinus rhythm (SR) in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF
    E.2.2Secondary objectives of the trial
    To compare the effects of flecainide acetate inhalation solution and placebo on the time to conversion of AF to SR, AF-related symptoms, hospitalizations, AF-related interventions, and the time to discharge in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥18 and ≤85 years of age
    2. Recent onset of symptomatic newly diagnosed or paroxysmal AF
    a) Recent onset is defined as a symptom duration ≥1 and ≤48 hours at time of dosing.
    b) Newly diagnosed AF is AF that has not been diagnosed previously, independent of its duration.
    c) Paroxysmal AF is defined as recurrent AF in a patient whose previous AF episode(s) self-terminated (ie, without treatment) or terminated with intervention ≤7 days of onset.
    d) A symptomatic recent-onset AF episode post cardiac ablation for paroxysmal AF would be considered eligible.
    E.4Principal exclusion criteria
    1. History of non self-terminating AF/atrial flutter:
    a) One or more failed attempts to restore SR with pharmacological therapy
    b) ECV procedure for an AF episode ≤1 year prior to screening. Exception: One (1) prior ECV is allowed if no option for pharmacological conversion was previously available
    c) More than 3 ECV procedures in ≤5 years prior to screening
    2. Current diagnosis of persistent AF
    3. One or more episodes of AFL ≤6 months prior to randomization
    4. Hemodynamic or cardiac instability during AF, defined as at least 3 consecutive measurements of any of the following during screening:
    a) Systolic blood pressure (SBP) <100 or ≥160 mmHg
    b) Diastolic blood pressure (DBP) ≥95 mmHg
    c) Ventricular HR <80 or >160 bpm
    5. Respiratory rate >22 breaths per minute
    6. History of decompensated heart failure
    7. Evidence of significant HF defined as any of the following:
    a) Hospitalization in the last 12 months for HF or suspected HF event
    b) Most recent assessment of left ventricular ejection fraction <45%
    c) New York Heart Association Class II-IV symptoms
    d) Medication history suggestive of HF per the Investigator's discretion
    8. Signs or symptoms of ongoing myocardial ischemia, including any of the following:
    a) Significant ST segment elevation or depression (ie, ≥2 mm) on a standard 12-lead ECG
    b) Echocardiogram findings (eg, wall motion abnormalities) suggestive of acute myocardial infarction
    c) Angina pectoris, atypical angina pectoris, or receiving antianginal medication for ischemia
    9. History of MI ≤3 months of screening
    10. History of uncorrected moderate or severe aortic or mitral valvular stenosis, in the opinion of the Investigator
    a) If an echocardiogram is performed at screening, moderate or severe valvular stenosis observed during the examination is considered exclusionary.
    11. History of LV hypertrophy with LV thickness >12 mm as observed in the most recent assessment, ie, an echocardiogram
    12. Stroke (including transient ischemic attack) ≤3 months prior to randomization
    13. History of any of the following cardiac abnormalities:
    a) Long QT syndrome
    b) Conduction system disease
    c) Brugada syndrome
    d) Torsade de pointes
    e) Diagnosed with sinus node dysfunction or any of the following:
    i. History of unexplained or cardiovascular syncope
    ii. Bradycardia suggestive of sinus node dysfunction
    iii. Prior electrical or pharmacological cardioversion associated with sinus or ventricular pause >3 seconds or ventricular heart rate <45 bpm at time of conversion
    14. Any of the following ECG-related features at screening:
    a) QT interval corrected for heart rate using the Fridericia formula (QTcF) >480 msec
    b) Wide QRS complex (ie, duration ≥120 msec) or history of documented wide QRS complex tachycardia (ie, wide QRS complex with ventricular heart rate >100 bpm)
    c) Presence of VT. Site telemetry should be equipped with an alarm system for VT and premature ventricular complexes (PVCs) or be continuously visually observed prior to dosing.
    15. Presence of a pacemaker
    16. Cardiac surgery for any of the exclusionary conditions (eg, valvular disease, hypertrophy, coronary artery disease) ≤6 months prior to randomization
    17. Known severe renal impairment or patient receiving dialysis
    18. Known abnormal liver function, including hepatic disease or biochemical evidence of significant liver derangement
    19. Uncorrected hypokalemia
    20. Uncorrected hypomagnesemia
    21. Chronic obstructive pulmonary disease or other established pulmonary disease in need of inhalation medication
    22. History of bronchospasm (eg, hyperreactive airways to inhalants) or difficulty inhaling medications
    23. Previous or current hospitalization for COVID-19, or any secondary cardiomyopathy from COVID-19
    24. Treatment with Class I or III AADs ≤7 days prior to randomization
    25. Treatment with amiodarone ≤12 weeks prior to randomization
    26. Known hypersensitivity to flecainide acetate, any active metabolites of flecainide acetate, or any excipients in FlecIH-103
    27. Any condition or circumstance which in the opinion of the Investigator may make the patient unsuitable for the study
    28. Known drug or alcohol dependence ≤12 months prior to screening as judged by the Investigator
    29. A body mass index >35 kg/m2
    30. Legally incompetent to provide informed consent
    31. Previous treatment with any other investigational drug ≤30 days from screening or 5 half-lives of the drug, whichever is longer
    32. Female of childbearing potential
    33) Males whose sexual partners are women of childbearing potential (WOCBP), unless they use at least one highly effective method of contraception during the study or are permanently sterile by bilateral orchiectomy
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients whose AF converts to SR ≤90 minutes after initiation of dosing
    E.5.1.1Timepoint(s) of evaluation of this end point
    ≤90 minutes after initiation of dosing
    E.5.2Secondary end point(s)
    1) The time to conversion of AF to SR ≤90 minutes after initiation of dosing
    2) The proportion of patients with AF-related symptoms at the 90 minute time point
    3) The proportion of patients requiring hospitalization prior to discharge
    4) The prevalence (ie, events per patient) of additional AF-related interventions required prior to discharge
    5) The time to discharge-eligible status
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) ≤90 minutes after initiation of dosing
    2) 90 minutes after initiation of dosing
    3) prior to discharge
    4) discharge-eligible status
    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 Yes
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Canada
    United States
    Poland
    Netherlands
    Spain
    Czechia
    Hungary
    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
    A patient will have fulfilled the requirements for study completion if/when the patient has completed the 96-hour follow-up contact.
    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 months9
    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 months1
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 400
    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)
    The Investigator may offer an alternative and/or additional treatment >90 minutes after initiation of dosing, within the institutional standard of care. The choice of the treatment is guided by patient-specific factors and patient preferences and is left to the discretion of the treating physician and to patient’s approval, with the exception of sotalol, procainamide or ibutilide, which are not allowed through the 96 hour follow-up contact.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation WCN
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation CYTE
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-15
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