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    Summary
    EudraCT Number:2012-000181-37
    Sponsor's Protocol Code Number:CVT-301-002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-27
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-000181-37
    A.3Full title of the trial
    A Randomized, Placebo-Controlled Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CVT-301 (Levodopa Inhalation Powder) in Patients with Parkinson’s Disease and Motor Response Fluctuations (“Off” Episodes)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating the safety of CVT-301 in patients with Parkinson's Disease
    A.4.1Sponsor's protocol code numberCVT-301-002
    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 SponsorCivitas 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 supportCivitas Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationi3 International (UK) Limited
    B.5.2Functional name of contact pointGlobal Regulatory Start-up Manager
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Star House, 20 Grenfell Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 1EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628641884
    B.5.5Fax number00441628408401
    B.5.6E-maili3regulatory@i3global.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 nameCVT-301
    D.3.2Product code CVT-301
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeCVT-301
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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) 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Sinemet®
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSINEMET® Plus 25 mg/100 mg Tablets
    D.3.4Pharmaceutical form Tablet
    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 INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 38821-49-7
    D.3.9.3Other descriptive nameCARBIDOPA MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21619
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboInhalation powder, hard capsule
    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
    Parkinson's Disease
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10034007
    E.1.2Term Parkinson's disease NOS
    E.1.2System Organ Class 10029205 - Nervous system 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 characterize the safety and tolerability of inhaled CVT 301 in Parkinson’s disease patients experiencing “off” episodes
    E.2.2Secondary objectives of the trial
    To characterize the input phase pharmacokinetic (PK) profile of single, inhaled doses of levodopa in patients with Parkinson’s disease experiencing “off” episodes

    To evaluate the pharmacodynamics of single, inhaled doses of levodopa or a standard oral dose of levodopa in patients with Parkinson’s disease experiencing “off” episodes

    Exploratory Objective
    To describe and model the relationship of levodopa plasma concentration to motor response
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has signed and dated an IEC-approved informed consent form before any protocol specific screening procedures are performed.
    2. Has a clinical diagnosis of idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the UK Brain Bank criteria, diagnosed at an age of 30 to 80 years, inclusive.
    3. Is a male or female over the age of 30 years. Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
    4. Is classified as Stage 1 to 3 (in the “on” state) on the modified Hoehn and Yahr scale for staging of PD severity.
    5. Is levodopa-responsive (as documented by the investigator) with a PD medication regimen that includes a levodopa/DDI-containing regimen at least 4 times during the waking day. Levodopa-containing regimens must be stable for at least 2 weeks prior to
    screening.
    6. If treated with dopamine agonists, COMT inhibitors, MAO-B inhibitors, or other nonlevodopa-containing PD medications, must be on a stable dose for at least 4 weeks prior to screening and must remain stable throughout the study.
    7. Has not received apomorphine for at least 2 weeks prior to screening and agrees not to be treated with apomorphine for the duration of the study.
    8. Experiences motor fluctuations with recognizable and predictable “off” periods and has an average of at least 2 hours of “off” time per waking day, exclusive of early morning “off” time (by self-report). Patients should be able to recognize their “wearing off” symptoms and verify that they usually improve after their next dose of PD medication.
    9. If a current smoker, is able to comply with the following guidelines: agrees not to smoke on the mornings of study dosing days and for the entire study dosing day until completion of all study procedures.
    10. Is willing and able to complete all study assessments and procedures.
    11. Has an FEV1 greater than 70% of predicted for race, age, sex, and height, and FEV1/FVC (forced vital capacity) ratio greater than or equal to 75%, in the “on” state.
    12. Patients may be taking anti-depressant medication, but the dose must be stable for at least 4 weeks prior to screening.
    13. Understands (with or without carer assistance) his/her daily PD medications.
    14. Is able (with or without carer assistance) to attend all study visits.
    E.4Principal exclusion criteria
    1. Is a pregnant or lactating woman.
    2. Has severe dyskinesia that would significantly interfere with the patient’s ability to perform study assessments.
    3. Has any condition that in the investigator’s opinion would make the patient unsuitable for participation in the study and/or medical condition that, in the opinion of the investigator, would interfere with participation in this study.
    4. Has a history of chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory diseases within the last 5 years, or is currently receiving treatment for any of these conditions.
    5. Has used neuroleptics, reserpine, or catecholaminergic blocking agents within the last 3 months.
    6. Has received dopamine agonist blocking agents and/or non-specific monoamine oxidase inhibitors (MAOIs) within the last 3 months; however, domperidone is allowed if the maximum daily dose does not exceed 60 mg and if the dose has been stable for at least 4 weeks prior to screening.
    7. Has a history of psychotic symptoms requiring treatment with an antipsychotic medication within the past 12 months; however, certain low-dose atypical antipsychotic agents (prescribed for conditions other than psychosis) are allowed if the dose has been
    stable for at least 8 weeks prior to screening (quetiapine ≤50 mg/day, risperidone ≤1 mg/day, and olanzipine ≤2.5 mg/day).
    8. Has a history of suicidal ideation or suicide attempt within the past 12 months.
    9. Has had previous surgery for PD or is planning stereotactic surgery during the study period.
    10. In the opinion of the investigator (or carer, as applicable), has signs/symptoms suggestive of clinically significant cognitive impairment that would interfere with the ability to comply with study procedures.
    11. Has a history of any primary malignancy, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 3 years.
    12. Has a history within 12 months prior to screening of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR).
    13. Has a QTcF interval of ≥450 msec for males or ≥470 msec for females, or has a clinically significant abnormal ECG as assessed by a qualified physician at screening.
    14. Has any clinically significant abnormality following review of screening laboratory data, previous medical history or intercurrent illness, and physical examination data that, in the investigator’s opinion, may compromise the safety of the patient in the study.
    15. Has been treated with an investigational drug within 4 weeks or 5 half-lives (whichever is longer) prior to the beginning of the screening period (this includes investigational formulations of marketed products).
    16. Has had >500 mL of blood collected within 8 weeks prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics
    Baseline-adjusted maximum concentration (ΔCmax = Cmax - C0), time to maximum concentration (tmax), and baseline-adjusted partial area under the concentration-time curve (pAUC), e.g. at 5 0 (pAUC0-5) and 10 (pAUC0-10) minutes postdosing.

    Pharmacodynamics
    • Areas under the curve (AUC) from 0 - 3 hours.
    • Average response for all assessments at 0 to 3 hours after the dose of study medication

    • Best response for all assessments at 0-3 hours after the dose of study medication
    • Early effect, defined as average response of assessments at 0-30 minutes after the dose of study medication
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic Endpoints:
    5 and 10 minutes post-dosing

    Pharmacodynamic Endpoints:
    Up to 3 hours post-dosing
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 No
    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) 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 No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned3
    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 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
    Israel
    Serbia
    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 Subject Last Visit
    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 years0
    E.8.9.2In all countries concerned by the trial months9
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 24
    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)
    Subjects will continue with standard of care treatment after ending participation in the trial.
    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 Decision2012-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-29
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