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    The EU Clinical Trials Register currently displays   41225   clinical trials with a EudraCT protocol, of which   6755   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-003513-24
    Sponsor's Protocol Code Number:IN11004OLE
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-003513-24
    A.3Full title of the trial
    An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004
    A.4.1Sponsor's protocol code numberIN11004OLE
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02615873
    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 SponsorIntec Pharma, Ltd.
    B.1.3.4CountryIsrael
    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 supportIntec Pharma, Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntec Pharma, Ltd.
    B.5.2Functional name of contact pointClinical Affairs
    B.5.3 Address:
    B.5.3.1Street Address12 Hartom St., P.O. Box 45219
    B.5.3.2Town/ cityJerusalem
    B.5.3.3Post code9777512
    B.5.3.4CountryIsrael
    B.5.4Telephone number+97225864657
    B.5.5Fax number+97225869176
    B.5.6E-maillinda@intecpharma.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 nameAccordion Pill™ Carbidopa/Levodopa 50/400 mg
    D.3.4Pharmaceutical form Capsule
    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 INNCarbidopa
    D.3.9.3Other descriptive nameCARBIDOPA
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevodopa
    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 number400
    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.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 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 nameAccordion Pill™ Carbidopa/Levodopa 50/500 mg
    D.3.4Pharmaceutical form Capsule
    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 INNCarbidopa
    D.3.9.3Other descriptive nameCARBIDOPA
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevodopa
    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 number500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10034005
    E.1.2Term Parkinson's disease and parkinsonism
    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
    To determine the long-term safety and tolerability of AP-CD/LD in subjects with advanced PD who completed the core study IN 11 004.
    E.2.2Secondary objectives of the trial
    The secondary objective to determine the long-term clinical benefit of AP-CD/LD in subjects with advanced PD who completed the core study IN 11004
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients who successfully completed the core study ‎IN 11 004 and, in the opinion of the Investigator would benefit from long-term treatment with AP-CD/LD
    2.Continue to carry the diagnosis of Parkinson`s disease consistent with UK brain bank criteria
    2.Patients who have a good response to levodopa in the opinion of the investigator
    3.Subjects able and willing to give written (signed and dated) informed consent to participate in the study

    E.4Principal exclusion criteria
    1.Participation in a clinical trial other than study IN 11 004 and receipt of an investigational medication other than those administered in study IN 11 004, within 28 days prior to the planned
    start of treatment
    2.Previous or planned functional neurosurgical or Duodopa treatment for
    Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation)
    3.Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation.
    4.If, in the opinion of the Investigator, subject should not participate
    in the study
    5.Women who are pregnant or nursing. Women of childbearing
    potential who are not willing to use a medically acceptable method of contraception. Medically
    acceptable methods of contraception that may be used by the patient and /or partner include: True
    abstinence when this is in line with the preferred and usual lifestyle of the patient, oral contraceptive agents, intrauterine devices (IUDs), implantable contraceptives (e.g., Norplant),
    transdermal hormonal contraceptives (e.g., Ortho-Evra), and injectable contraceptives (e.g.,
    Depo-Provera), condom and /or diaphragm, diaphragm with vaginal spermicide, surgical sterilization
    (6 months), or postmenopausal females (no menstrual period for > 2years) or vasectomy ( > 6 months)
    . The current contraceptive therapy must be maintained through the end of the study (End of study
    visit or final follow-up phone visit, whichever is later).
    Hormonal contraceptive therapy must be a stable dose for at least 90
    days prior to first study drug administration.
    E.5 End points
    E.5.1Primary end point(s)
    Safety measures:
    1. Adverse Events
    2. Specific evaluation of GI complaints (Adverse events of special
    interest)
    3. Withdrawal rates, days and reason to withdrawals
    4. Safety laboratory (hematology, biochemistry, Vitamin B12, Folic Acid
    and urinalysis)
    5. Vital signs
    6. Electrocardiogram (ECG)
    7. Physical examination
    8. Orthostatic hypotension evaluation
    9. Evaluation of suicidality using the Columbia Suicide Severity Rating
    Scale (C-SSRS) baseline (Visit 1) to EOS (Visit 7) visit
    10. Assessment of impulse control using the Questionnaire for
    Impulsive-Compulsive Disorders in Parkinson's Disease–Rating Scale
    (QUIP-RS)
    11. Change from baseline (Visit 1) to EOS (Visit 7) visit in the Scales for
    Outcomes in Parkinson's Disease - Epworth Sleepiness Scale (ESS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    On an ongoing basis
    E.5.2Secondary end point(s)
    Efficacy Outcome Measures:
    The following efficacy endpoints are predefined as secondary endpoints for approximately the first 150 enrolled patients.
    1. Change from Baseline to EOS in the percentage and total hours of
    daily "Off time" during waking hours based on Hauser Home Diary
    assessments; Total number of "Off " hours normalized to a 16- hour
    waking day will also be calculated but only a single p-value applicable to
    both the percentage and hours will be reported.
    2. Change from Baseline to EOS in "On time" without troublesome
    dyskinesia during waking hours
    3. Change from Baseline to EOS in the number of daily Levodopa doses
    4. CGI-I at EOS as recorded by physician (all enrolled patients)
    5. CGI-I at EOS as recorded by patient (all enrolled patients)
    6. Change from Baseline in total UPDRS Score (Sum of Parts I-III)
    7. Change from Baseline to EOS in UPDRS Part II (Activities of Daily
    Living)
    8. Change from Baseline to EOS in UPDRS Motor Examination (part III -
    evaluated 2-3 hours after last LD dose)
    9. Change from Baseline to EOS in PDQ-39 summary index
    10. Change from Baseline to EOS in troublesome dyskinesia
    11. Change from Baseline to EOS in "On time" without dyskinesia
    during waking hours.
    In addition, the following exploratory efficacy endpoints will be
    evaluated.
    • Change from Baseline to EOS in the Parkinson's Disease Sleep Scale
    (PDSS-2)
    • Change from Baseline to EOS (hours during waking time) for each
    diary category not listed as secondary endpoint
    • Change from Baseline to EOS in the Freezing of Gait
    • Change from Baseline to EOS in Morning Akinesia
    • Change from Baseline to EOS of percentage of time during waking
    hours of each diary category excluding sleep time and "Off time"
    • Change from Baseline to EOS in UPDRS part IV, evaluated as
    dyskinesia sum score (sum of items 32-35) and wearing-off sum score
    (sum of items 36-39).
    E.5.2.1Timepoint(s) of evaluation of this end point
    On an ongoing basis.
    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 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Bulgaria
    Germany
    Israel
    Italy
    Poland
    Slovakia
    Spain
    Ukraine
    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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days6
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 186
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 266
    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)
    Standard treatment
    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 Decision2016-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-06
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