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    Summary
    EudraCT Number:2012-005822-31
    Sponsor's Protocol Code Number:CVT-301-003
    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:2013-03-05
    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 number2012-005822-31
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s disease
    A.3.2Name or abbreviated title of the trial where available
    Inhaled CVT-301 in Subjects with Parkinson’s Disease
    A.4.1Sponsor's protocol code numberCVT-301-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01777555
    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 organisationINC Research
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressRiver View, The Meadows Business Park, Station Approach
    B.5.3.2Town/ cityCamberley
    B.5.3.3Post codeGU179AB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044127648 1000
    B.5.5Fax number0044127635 743
    B.5.6E-mailSM_Regaffairs_eu_ap@incresearch.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.3.9.3Other descriptive nameLEVODOPA
    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 number17
    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 placeboCapsule, hard
    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 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is to compare the effects of CVT-301 Dose Level 2 (DL2; high dose) and placebo on the mean change from pre-dose in average UPDRS Part 3 motor score at 10 to 60 minutes following treatment of patients experiencing an OFF episode at the end-of-treatment (EOT) visit (Visit 6).
    E.2.2Secondary objectives of the trial
    - Compare the effects of CVT-301 and placebo on the mean time to resolution of an OFF episode to an ON state at each dose level
    - Characterize the effects of CVT-301 and placebo on daily ON time with and without troublesome dyskinesia
    - Characterize the safety and tolerability of CVT-301 when used chronically to provide relief from OFF episodes overall and at each dose level
    - Compare the effects of CVT-301 DL1 and placebo on the mean change from pre-dose in the average UPDRS Part 3 motor score at 10 to 60 minutes
    - Compare the effects of CVT-301 and placebo on the mean change from pre-dose in the UPDRS Part 3 motor score at specified time points following observed treatment of patients experiencing an OFF episode at each visit at each dose level
    - Characterize the effects of CVT-301 on safety, including acute and chronic pulmonary safety using spirometry, electrocardiograms, vital signs, and clinical laboratory tests overall
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to enter the study, patients must meet all of the following criteria:
    1.Has signed and dated an IRB/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 after the age of 30 years.
    3.Is a male or female aged 30 to 80 years, inclusive. Women of child-bearing potential must use protocol-defined contraceptive measures (see Section 11.1.5) 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 LD-responsive (as documented by the investigator) with a PD medication regimen that includes a LD/DDI-containing regimen at least 4 times during the waking day. LD-containing regimens must be stable for at least 2 weeks prior to screening.
    6.Has normal cognition as confirmed by a score of ≥25 on the Mini Mental State Examination (MMSE).
    7.Has a difference in UPDRS Part 3 scores of ≥25% between ON and OFF states during screening.
    8.If treated with dopamine agonists, COMT inhibitors, MAO-B inhibitors, or other non-LD-containing PD medications, must be on a stable dose for at least 4 weeks prior to screening and must remain stable throughout the study.
    9.Has not received apomorphine for at least 4 weeks prior to screening and agrees not to be treated with apomorphine for the duration of the study.
    10.Experiences motor fluctuations with recognizable and predictable OFF episodes and has an average of at least 2 hours of OFF time per waking day, exclusive of early morning OFF time (by self-report and confirmed by diary). Patients should be able to recognize their “wearing off” symptoms and verify that they usually improve after their next dose of PD medication.
    11.Is willing and able to complete all study assessments and procedures.
    12.If a current smoker, is able to comply with the following guidelines: agrees not to smoke for the entire clinic visit days (including screening visits, in-clinic treatment visits, and follow-up visit) until completion of all study procedures.
    13.If the patient is a current or former smoker, has no history of, nor has ever been treated for any smoking-related pulmonary condition (e.g., chronic bronchitis, emphysema, chronic obstructive pulmonary disease [COPD]) or asthma, and has no evidence of obstructive lung disease by spirometry assessment. Patient must agree to abstain from smoking on the day of each in-clinic visit from waking through completion of all assessments for that visit day.
    14.Has a screening FEV1 greater than 60% of predicted for race, age, sex, and height, and FEV1/FVC ratio greater than or equal to 75%, in the ON state.
    15.If taking anti-depressant medication, the anti-depressant dose must be stable for at least 4 weeks prior to screening.
    16.Understands (with or without caregiver assistance) his/her daily PD medications.
    17.Is able (with or without caregiver assistance) to attend all study visits.
    E.4Principal exclusion criteria
    Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study:
    1.Is a pregnant or lactating woman.
    2.Has dyskinesia of a severity that might significantly interfere with the patient’s ability to perform study procedures and assessments.
    3.Has a current history of symptomatic orthostatic hypotension despite adequate treatment.
    4.Has any known contraindication to the use of LD, including a history of malignant melanoma or a history of narrow-angle glaucoma.
    5.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.
    6.Has a history of COPD, asthma, or other chronic respiratory diseases within the last 5 years, or is currently receiving treatment for any of these conditions.
    7.Has any contraindication to performing routine spirometry (see Appendix 12 for a list of contraindications).
    8.Has used reserpine or catecholaminergic blocking agents within the last 3 months.
    9.Has a history of psychotic symptoms requiring treatment with an antipsychotic medication within the past 12 months; however, in regions where they are approved, certain low-dose atypical antipsychotic agents (which may be 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).
    10.Has received dopamine agonist blocking agents and/or non-specific monoamine oxidase inhibitors (MAOIs) within the last 3 months; however, in regions where it is approved, use of domperidone is permitted 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.
    11.Has a history of suicidal ideation or suicide attempt within the past 12 months.
    12.Has had previous stereotactic surgery or is planning surgery during the study period.
    13.In the opinion of the investigator (or caregiver, as applicable), has signs/symptoms suggestive of clinically significant cognitive impairment that would interfere with the ability to comply with study procedures.
    14.Has a history of any primary malignancy, with the exception of basal cell or successfully treated squamous cell carcinomas of the skin, cervical carcinoma in situ, or prostatic carcinoma in situ; or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.
    15.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).
    16.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.
    17.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).
    18.Has had any prior exposure to CVT-301.
    Note: An active or recent (within 3 days) respiratory infection will not disqualify a patient from enrolling in the study. However, all symptoms should be resolved for at least 3 days prior to the baseline visit (the screening period may be extended for up to 4 weeks to accommodate this recovery).
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints:
    The primary endpoint of the study is the mean change from pre-dose in the average UPDRS Part 3 score at 10 to 60 minutes post-dose. The differences between CVT 301 DL2 and placebo at the EOT visit (Visit 6) in the primary endpoint will be estimated using a Mixed Model for Repeated Measurements (MMRM).
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 to 60 minutes following treatment

    E.5.2Secondary end point(s)
    At-Home Objectives:
    To compare the effects of CVT-301 and placebo on the mean
    time to resolution of an OFF episode to an ON state during the 2-week at-home period at each dose level.
    To compare the effects of CVT-301 and placebo on the
    proportion of treated OFF episodes that resolve to an ON state
    overall and at pre-specified categorical time intervals following
    completion of CVT-301 and placebo inhalation during the 2-week
    at-home period at each dose level.
    To characterize the effects of CVT-301 and placebo on daily ON
    time with and without troublesome dyskinesia and the total daily
    OFF time from diaries with data collected for 3 days immediately
    prior to each visit at each dose level.
    To characterize the safety and tolerability of CVT-301 when
    used chronically to provide relief from OFF episodes overall and
    during the 2-week at-home period at each dose level.
    In-Clinic Objectives:
    To compare the effects of CVT-301 Dose Level 1 (DL1; low
    dose) and placebo on the mean change from pre-dose in the average
    UPDRS Part 3 motor score at 10 to 60 minutes following treatment
    of patients experiencing an OFF episode at the end of 1 week of
    treatment (Visit 4).
    To compare the effects of CVT-301 and placebo on the mean
    change from pre-dose in the UPDRS Part 3 motor score at specified
    time points following observed treatment of patients experiencing an
    OFF episode at each visit at each dose level.
    To compare the effects of CVT-301 and placebo on the time to
    objective motor response, defined as a ≥30% reduction from pre-
    dose in the UPDRS Part 3 motor score at each visit at each dose
    level.
    To compare the effects of CVT-301 and placebo on the number
    and proportion of patients achieving an objective motor response at
    each visit at each dose level.
    To compare the effects of CVT-301 and placebo on examiner-rated time to an ON state following observed treatment of patients
    experiencing an OFF episode at each visit at each dose level.
    To assess the occurrence, duration, and severity of dyskinesia
    following study treatment at each visit at each dose level.
    To characterize the effects of CVT-301 on safety, including
    acute and chronic pulmonary safety using spirometry,
    electrocardiograms (ECGs), vital signs (blood pressure, heart rate,
    respiratory rate), and clinical laboratory tests overall and at each visit (when assessed) at each dose level.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints are evaluated during the study conduct as mentioned above
    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 Yes
    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.8.2.4Number 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Italy
    Serbia
    United Kingdom
    United States
    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
    End of the trial is the last visit of the last patient globally.
    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 months11
    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 months11
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 80
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation DeNDRoN Coordinating Centre
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-21
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